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2028 lines
118 KiB
HTML
2028 lines
118 KiB
HTML
<!DOCTYPE html>
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<html xmlns="http://www.w3.org/1999/xhtml" lang='en'>
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<head>
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<meta charset="UTF-8">
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<title>History of Changes for Study: NCT01303796</title>
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<script src="html/images/../jquery/js/jquery.min.js?v=3.5.1"></script><noscript></noscript>
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<link rel="stylesheet" type="text/css" href="html/css/HistoryDiffsStyle.css?v=b40">
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<link rel="stylesheet" type="text/css" href="html/css/w3-ct.css?v=b36">
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<meta name="viewport" content="width=device-width, initial-scale=1">
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<meta name="ncbi_app" content="ctgov-archive" />
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<meta name="ncbi_db" content="ctgov" />
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<meta name="ncbi_pdid" content="HomePage" />
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</head>
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<body>
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<div id="ArchiveHeader" class="wrapper"><img class="responsive-image"
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src="html/images/ct.gov-nlm-nih-archive-logo.png" alt="ClinicalTrials.gov" style="margin:2px;">
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</div>
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<hr class="fancyDivider" style="clear:both;">
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<div id="controls" class="wrapper">
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<div style="text-align:center;font-size:larger;font-weight:bold;padding:14px 10px 0;">History of Changes for Study:
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NCT01303796</div>
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<div style="text-align:center;font-size:larger;font-weight:bold;padding:14px 10px;">A Study of Oral Sapacitabine in
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Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS)</div>
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<div style="text-align:center;font-size:smaller;margin-bottom:10px;"><a
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href="https://clinicaltrials.gov/ct2/show/NCT01303796">Latest version (submitted October 28, 2018) on
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ClinicalTrials.gov</a></div>
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<div style="clear:both;"></div>
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<div class="w3-container">
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<div class="w3-row">
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<div class="w3-col l4" style="float:right;">
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<div style="font-size:smaller;padding:10px; color:navy;">
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<ul class="instructions">
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<li>A study version is represented by a row in the table.</li>
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<li>Select two study versions to compare. One each from columns A and B.</li>
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<li>Choose either the "Merged" or "Side-by-Side" comparison format to specify how the
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two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of
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the study.</li>
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<li>Click "Compare" to do the comparison and show the differences.</li>
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<li>Select a version's Submitted Date link to see a rendering of the study for that version.</li>
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<li>The <span style="background-color: lightyellow;"> yellow A/B </span>choices in the table indicate the
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study versions currently compared below. A<span style="background-color: lightyellow;"> yellow
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</span>table row indicates the study version currently being viewed.</li>
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<li>Hover over the "<span class="recruitmentStatus">Recruitment Status</span>" to see how the
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study's recruitment status changed.</li>
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<li>Study edits or deletions are displayed in <span class="drop_hilite">red</span>.</li>
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<li>Study additions are displayed in <span class="add_hilite">green</span>.</li>
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</ul>
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</div>
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</div>
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<div class="w3-col l8" style="float:left;">
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<form action="#StudyPageTop" data-ncbi-sg-search="true" onsubmit="sendSearchPing();" method="GET">
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<div class="w3-responsive">
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<fieldset class="releases ct-StdBackground">
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<legend class="releases">Study Record Versions</legend>
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<table class="w3-bordered releases">
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<thead>
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<tr>
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<th style="text-align:center;border-right:1px solid dimgrey;" id="VersionNumber">Version</th>
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<th style="text-align:center;border-right:1px solid dimgrey;" id="ColumnA">A</th>
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<th style="text-align:center;border-right:1px solid dimgrey;" id="ColumnB">B</th>
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<th style="text-align:center;border-right:1px solid dimgrey;white-space:nowrap;" id="VersionDate">
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Submitted Date</th>
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<th style="text-align:center; width:100%;" id="Changes">Changes</th>
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</tr>
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</thead>
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<tbody>
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<tr>
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<td headers="VersionNumber">1</td>
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<td headers="ColumnA" class="currentChoice"><input type="radio" name="A"
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title="Column A, study version 1" value="1" checked></td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 1" value="1">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_1=View#StudyPageTop" title="View study version (1) dated February 24, 2011">February
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24, 2011</a>
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</td>
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<td style="text-align:left;" headers="Changes">None (earliest Version on record)
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<tr>
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<td headers="VersionNumber">2</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 2" value="2">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 2" value="2">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_2=View#StudyPageTop" title="View study version (2) dated March 23, 2011">March 23,
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2011</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">3</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 3" value="3">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 3" value="3">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_3=View#StudyPageTop" title="View study version (3) dated April 11, 2011">April 11,
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2011</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">4</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 4" value="4">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 4" value="4">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_4=View#StudyPageTop" title="View study version (4) dated November 7, 2011">November
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7, 2011</a>
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</td>
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<td style="text-align:left;" headers="Changes">Sponsor/Collaborators, Study Status,
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Contacts/Locations and Oversight</td>
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</tr>
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<tr>
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<td headers="VersionNumber">5</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 5" value="5">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 5" value="5">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_5=View#StudyPageTop" title="View study version (5) dated May 2, 2012">May 2, 2012</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status, Outcome Measures, Arms and
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Interventions, Study Description, Contacts/Locations and Study Design</td>
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</tr>
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<tr>
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<td headers="VersionNumber">6</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 6" value="6">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 6" value="6">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_6=View#StudyPageTop" title="View study version (6) dated May 3, 2012">May 3, 2012</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">7</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 7" value="7">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 7" value="7">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_7=View#StudyPageTop" title="View study version (7) dated May 4, 2012">May 4, 2012</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">8</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 8" value="8">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 8" value="8">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_8=View#StudyPageTop" title="View study version (8) dated May 7, 2012">May 7, 2012</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">9</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 9" value="9">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 9" value="9">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_9=View#StudyPageTop" title="View study version (9) dated May 14, 2012">May 14,
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2012</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">10</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 10" value="10">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 10" value="10">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_10=View#StudyPageTop" title="View study version (10) dated July 11, 2012">July 11,
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2012</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">11</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 11" value="11">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 11" value="11">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_11=View#StudyPageTop"
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title="View study version (11) dated September 25, 2012">September 25, 2012</a>
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</td>
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<td style="text-align:left;" headers="Changes">Study Status and Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">12</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 12" value="12">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 12" value="12">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_12=View#StudyPageTop"
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title="View study version (12) dated December 14, 2012">December 14, 2012</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">13</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 13" value="13">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 13" value="13">
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</td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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|
href="?V_13=View#StudyPageTop"
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|
title="View study version (13) dated November 14, 2013">November 14, 2013</a>
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</td>
|
|
<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
|
|
<td headers="VersionNumber">14</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 14" value="14">
|
|
</td>
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|
<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 14" value="14">
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|
</td>
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|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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|
href="?V_14=View#StudyPageTop"
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|
title="View study version (14) dated February 10, 2014">February 10, 2014</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
|
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<td headers="VersionNumber">15</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 15" value="15">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 15" value="15">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_15=View#StudyPageTop" title="View study version (15) dated March 25, 2014">March 25,
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2014</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">16</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 16" value="16">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 16" value="16">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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|
href="?V_16=View#StudyPageTop"
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title="View study version (16) dated September 8, 2014">September 8, 2014</a>
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</td>
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
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</tr>
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<tr>
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<td headers="VersionNumber">17</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 17" value="17">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 17" value="17">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_17=View#StudyPageTop" title="View study version (17) dated April 13, 2015">April 13,
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2015</a>
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</td>
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<td style="text-align:left;" headers="Changes"><span class="recruitmentStatus"
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title="Recruiting --> Active, not recruiting">Recruitment Status</span>, Study Status and
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Contacts/Locations</td>
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</tr>
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<tr>
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<td headers="VersionNumber">18</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 18" value="18">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 18" value="18">
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</td>
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_18=View#StudyPageTop" title="View study version (18) dated August 17, 2015">August
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17, 2015</a>
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</td>
|
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<td style="text-align:left;" headers="Changes">Contacts/Locations and Study Status</td>
|
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</tr>
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<tr>
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<td headers="VersionNumber">19</td>
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<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 19" value="19">
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</td>
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<td headers="ColumnB"><input type="radio" name="B" title="Column B, study version 19" value="19">
|
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</td>
|
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<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
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href="?V_19=View#StudyPageTop" title="View study version (19) dated October 18, 2018">October
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18, 2018</a>
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</td>
|
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<td style="text-align:left;" headers="Changes"><span class="recruitmentStatus"
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title="Active, not recruiting --> Completed">Recruitment Status</span>, Study Status, Arms and
|
|
Interventions, Outcome Measures, Contacts/Locations, Study Design, Study Description, Oversight,
|
|
IPDSharing, References and Eligibility</td>
|
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</tr>
|
|
<tr style="border-bottom-width:0;">
|
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<td headers="VersionNumber">20</td>
|
|
<td headers="ColumnA"><input type="radio" name="A" title="Column A, study version 20" value="20">
|
|
</td>
|
|
<td headers="ColumnB" class="currentChoice"><input type="radio" name="B"
|
|
title="Column B, study version 20" value="20" checked></td>
|
|
<td style="text-align:right;white-space:nowrap;" headers="VersionDate"><a
|
|
href="?V_20=View#StudyPageTop" title="View study version (20) dated October 28, 2018">October
|
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28, 2018</a>
|
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</td>
|
|
<td style="text-align:left;padding-bottom:0;" headers="Changes">Arms and Interventions and Study
|
|
Status</td>
|
|
</tr>
|
|
<tr class="rsEvents-row rsEvents20-row">
|
|
<!--empty to keep even/odd shading correct-->
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</tr>
|
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<tr class="rsEvents-row">
|
|
<td class="rsEvents-control" colspan="3">
|
|
<div id="rsEvents20-show" class="rsEvents rsEvents-control"
|
|
title="Open this version's list of Results Submission Events"
|
|
onclick="$('.rsEvents20-row').toggle('fast');$('#rsEvents20-show').toggle();$('#rsEvents20-hide').toggle();">
|
|
<img class="ToggleImage" src="/html/images/expand.png" alt="Show"></div>
|
|
<div id="rsEvents20-hide" class="rsEvents rsEvents-control"
|
|
title="Close this version's list of Results Submission Events" style="display:none;"
|
|
onclick="$('.rsEvents20-row').toggle('fast');$('#rsEvents20-show').toggle();$('#rsEvents20-hide').toggle();">
|
|
<img class="ToggleImage" src="/html/images/collapse.png" alt="hide"></div>
|
|
</td>
|
|
<td colspan="2" style="padding:0 0 6px 4px;">
|
|
<div class="rsEvents" style="text-align:left;"> Results Submission Events</div>
|
|
</td>
|
|
</tr>
|
|
<tr class="rsEvents-row rsEvents20-row" style="display:none;">
|
|
<!--empty to keep even/odd shading correct-->
|
|
</tr>
|
|
<tr class="rsEvents-row rsEvents20-row" style="display:none;">
|
|
<td colspan="4">
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|
<div class="rsEvents rsEvents-submit">December 7, 2021<br>March 23, 2022</div>
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</td>
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<td>
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<div class="rsEvents rsEvents-result">Returned after QC review: January 4, 2022<br>Returned
|
|
after QC review: April 20, 2022</div>
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</td>
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</tr>
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</tbody>
|
|
</table>
|
|
<div class="w3-left-align" style="margin-top:10px;">
|
|
<input type="submit" class="compareButton" value="Compare" title="Compare" autofocus />
|
|
<div class="controls">
|
|
<span style="white-space:nowrap;">Comparison Format:</span>
|
|
<ul class="format w3-left-align">
|
|
<li><label for="mergedCB" title="Use merged format everywhere">
|
|
<input type="radio" id="mergedCB" name="C" value="merged" checked> Merged
|
|
</label></li>
|
|
<li><label for="sbsCB" title="Side-by-Side (applies only to Protocol Section)">
|
|
<input type="radio" id="sbsCB" name="C" value="Side-by-Side"> Side-by-Side
|
|
</label></li>
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|
</ul>
|
|
</div>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</div>
|
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</div>
|
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</div>
|
|
</div>
|
|
<a id="StudyPageTop"></a>
|
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<hr class="fancyDivider" style="margin:2px auto;">
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<div class="wrapper" style="text-align:center;font-weight:bold;">
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Changes (Merged) for Study: NCT01303796<br>
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February 24, 2011 (v1) -- October 28, 2018 (v20)<br><br>Changes in: <a href="#StudyStatus" target="_self"
|
|
title="Jump to the Study Status module" style="white-space:nowrap;">Study Status</a>, <a
|
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href="#SponsorCollaborators" target="_self" title="Jump to the Sponsor/Collaborators module"
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style="white-space:nowrap;">Sponsor/Collaborators</a>, <a href="#Oversight" target="_self"
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title="Jump to the Oversight module" style="white-space:nowrap;">Oversight</a>, <a href="#StudyDescription"
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target="_self" title="Jump to the Study Description module" style="white-space:nowrap;">Study Description</a>, <a
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href="#StudyDesign" target="_self" title="Jump to the Study Design module" style="white-space:nowrap;">Study
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Design</a>, <a href="#ArmsandInterventions" target="_self" title="Jump to the Arms and Interventions module"
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style="white-space:nowrap;">Arms and Interventions</a>, <a href="#OutcomeMeasures" target="_self"
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title="Jump to the Outcome Measures module" style="white-space:nowrap;">Outcome Measures</a>, <a
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href="#Eligibility" target="_self" title="Jump to the Eligibility module"
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style="white-space:nowrap;">Eligibility</a>, <a href="#ContactsLocations" target="_self"
|
|
title="Jump to the Contacts/Locations module" style="white-space:nowrap;">Contacts/Locations</a>, <a
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href="#IPDSharing" target="_self" title="Jump to the IPDSharing module"
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style="white-space:nowrap;">IPDSharing</a>, <a href="#References" target="_self"
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title="Jump to the References module" style="white-space:nowrap;">References</a>
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</script><noscript></noscript>
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</div>
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<hr>
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<table class="history">
|
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<thead>
|
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<tr>
|
|
<th></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td colspan="2"><a id="Protocol"></a></td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyIdentification">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="StudyIdentification"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyIdentificationImg" class="toggleImage"
|
|
onclick="toggleModule('StudyIdentification');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Study Identification</legend>
|
|
<div id="StudyIdentificationBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Unique Protocol ID:</td>
|
|
<td>CYC682-12 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Brief Title:</td>
|
|
<td>A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
|
|
(SEAMLESS)</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Official Title:</td>
|
|
<td>A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed
|
|
Acute Myeloid Leukemia </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Secondary IDs:</td>
|
|
<td></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyStatus">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="StudyStatus"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyStatusImg" class="toggleImage"
|
|
onclick="toggleModule('StudyStatus');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Study Status</legend>
|
|
<div id="StudyStatusBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Record Verification:</td>
|
|
<td><span class="drop_hilite">February 2011</span> <span class="add_hilite">October 2018</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Overall Status:</td>
|
|
<td><span class="drop_hilite">Recruiting</span> <span class="add_hilite">Completed</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Start:</td>
|
|
<td><span class="drop_hilite">January 2011</span> <span class="add_hilite">October 1,
|
|
2011</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Primary Completion:</td>
|
|
<td><span class="drop_hilite">September 2013 [Anticipated]</span> <span
|
|
class="add_hilite">December 15, 2016 [Actual]</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Completion:</td>
|
|
<td><span class="drop_hilite">March 2014 [Anticipated]</span> <span class="add_hilite">July 31,
|
|
2017 [Actual]</span> </td>
|
|
</tr>
|
|
<tr style="border-bottom:1px solid lightgray">
|
|
<td colspan="3"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">First Submitted:</td>
|
|
<td>February 21, 2011 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">First Submitted that<br />Met QC Criteria:</td>
|
|
<td>February 24, 2011 </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">First Posted:</td>
|
|
<td>February 25, 2011 [Estimate] </td>
|
|
</tr>
|
|
<tr style="border-bottom:1px solid lightgray">
|
|
<td colspan="3"></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Last Update Submitted that<br />Met QC Criteria:
|
|
</td>
|
|
<td><span class="drop_hilite">February 24, 2011</span> <span class="add_hilite">October 28,
|
|
2018</span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Last Update Posted:</td>
|
|
<td><span class="drop_hilite">February 25, 2011 [Estimate]</span> <span
|
|
class="add_hilite">October 31, 2018 [Actual]</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_SponsorCollaborators">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="SponsorCollaborators"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="SponsorCollaboratorsImg" class="toggleImage"
|
|
onclick="toggleModule('SponsorCollaborators');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Sponsor/Collaborators</legend>
|
|
<div id="SponsorCollaboratorsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Sponsor:</td>
|
|
<td>Cyclacel Pharmaceuticals, Inc. </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Responsible Party:</td>
|
|
<td> <span class="add_hilite">Sponsor</span> </td>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Collaborators:</td>
|
|
<td></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_Oversight">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="Oversight"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="OversightImg" class="toggleImage"
|
|
onclick="toggleModule('Oversight');" src="html/images/collapse.png" alt='Open or close this module'>
|
|
Oversight</legend>
|
|
<div id="OversightBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">U.S. FDA-regulated Drug:</td>
|
|
<td> <span class="add_hilite">Yes</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">U.S. FDA-regulated Device:</td>
|
|
<td> <span class="add_hilite">No</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Data Monitoring:</td>
|
|
<td> <span class="add_hilite">Yes</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyDescription">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="StudyDescription"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyDescriptionImg" class="toggleImage"
|
|
onclick="toggleModule('StudyDescription');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Study Description</legend>
|
|
<div id="StudyDescriptionBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Brief Summary:</td>
|
|
<td>This Phase 3 study assesses <span class="drop_hilite">three </span> <span
|
|
class="add_hilite">two </span>drug regimens as the initial treatment of patients who are at
|
|
least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the
|
|
doctor does not recommend the use of standard intensive treatment or the patient has decided
|
|
not to receive standard intensive treatment after being fully informed about its benefits and
|
|
risks by his/her doctor. The <span class="drop_hilite">three </span> <span
|
|
class="add_hilite">two </span>drug regimens are sapacitabine administered in alternating
|
|
cycles with <span class="drop_hilite">decitabine, sapacitabine alone or </span> decitabine
|
|
<span class="add_hilite">or decitabine </span>alone. The purpose of the study is to learn
|
|
which drug regimen is more likely to keep AML in check as long as possible. </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Detailed Description:</td>
|
|
<td>This is a multicenter, randomized, Phase 3 study <span
|
|
class="add_hilite">("SEAMLESS") </span>comparing <span class="drop_hilite">three
|
|
</span> <span class="add_hilite">two </span>drug regimens (arms) as the front-line treatment
|
|
of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML)
|
|
who are not candidates for intensive induction chemotherapy. In Arm A, sapacitabine is
|
|
administered in alternating cycles with decitabine, <span class="drop_hilite">in Arm B
|
|
sapacitabine is administered alone </span> and in Arm C decitabine is administered alone.
|
|
The primary efficacy endpoint is overall survival. The study is designed to demonstrate an
|
|
improvement in overall survival of <span class="drop_hilite">either of two pairwise
|
|
comparisons: (1) </span> Arm A versus Arm <span class="drop_hilite">C or (2) Arm B versus
|
|
Arm </span> C. </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_Conditions">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="Conditions"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ConditionsImg" class="toggleImage"
|
|
onclick="toggleModule('Conditions');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Conditions</legend>
|
|
<div id="ConditionsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Conditions:</td>
|
|
<td>Acute Myeloid Leukemia </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Keywords:</td>
|
|
<td>AML </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_StudyDesign">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="StudyDesign"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="StudyDesignImg" class="toggleImage"
|
|
onclick="toggleModule('StudyDesign');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Study Design</legend>
|
|
<div id="StudyDesignBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Type:</td>
|
|
<td>Interventional</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Primary Purpose:</td>
|
|
<td>Treatment</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Phase:</td>
|
|
<td>Phase 3</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Interventional Study Model:</td>
|
|
<td>Parallel Assignment </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Number of Arms:</td>
|
|
<td><span class="drop_hilite">3</span> <span class="add_hilite">2</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Masking:</td>
|
|
<td>None (Open Label)</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Allocation:</td>
|
|
<td>Randomized</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Enrollment:</td>
|
|
<td><span class="drop_hilite">470 [Anticipated]</span> <span class="add_hilite">482
|
|
[Actual]</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_ArmsandInterventions">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="ArmsandInterventions"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ArmsandInterventionsImg" class="toggleImage"
|
|
onclick="toggleModule('ArmsandInterventions');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Arms and Interventions</legend>
|
|
<div id="ArmsandInterventionsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td colspan="2">
|
|
<table class="ArmsInterv">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:60%;">Arms</th>
|
|
<th>Assigned Interventions</th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr style="border:1px solid gray">
|
|
<td><span class="drop_hilite">Experimental: Arm A</span> <span
|
|
class="add_hilite">Experimental: Sapacitabine-decitabine alternating</span>
|
|
<div class="indent1"><span class="drop_hilite">Sapacitabine and decitabine</span>
|
|
<span class="add_hilite">Arm A sapacitabine administered in alternating cycles with
|
|
decitabine</span></div>
|
|
</td>
|
|
<td><span class="drop_hilite">Drug: Sapacitabine and decitabine</span> <span
|
|
class="add_hilite">Drug: Sapacitabine</span>
|
|
<div class="indent1"><span class="drop_hilite">Sapacitabine administered in
|
|
alternating cycles with decitabine</span> <span class="add_hilite">oral
|
|
sapacitabine capsules</span></div> <span class="add_hilite">Drug:
|
|
Decitabine</span>
|
|
<div class="indent1"><span class="add_hilite">decitabine intravenous
|
|
</span>
|
|
</div>
|
|
</td>
|
|
</tr>
|
|
<tr style="border:1px solid gray">
|
|
<td><span class="drop_hilite">Active Comparator: Arm B</span>
|
|
<div class="indent1"><span class="drop_hilite">Sapacitabine
|
|
</span>
|
|
</div>
|
|
</td>
|
|
<td><span class="drop_hilite">Drug: Sapacitabine</span>
|
|
<div class="indent1"><span class="drop_hilite">Sapacitabine alone
|
|
</span>
|
|
</div>
|
|
</td>
|
|
</tr>
|
|
<tr style="border:1px solid gray">
|
|
<td>Active Comparator: <span class="drop_hilite">Arm C</span> <span
|
|
class="add_hilite">Decitabine</span>
|
|
<div class="indent1"><span class="add_hilite">Arm C </span>Decitabine</div>
|
|
</td>
|
|
<td>Drug: Decitabine<div class="indent1"><span class="drop_hilite">Decitabine
|
|
alone</span> <span class="add_hilite">decitabine intravenous</span></div>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_OutcomeMeasures">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="OutcomeMeasures"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="OutcomeMeasuresImg" class="toggleImage"
|
|
onclick="toggleModule('OutcomeMeasures');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Outcome Measures</legend>
|
|
<div id="OutcomeMeasuresBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:3em;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="white-space:nowrap;width: 3em;">Primary Outcome Measures:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">1.</td>
|
|
<td>Overall survival<br>[ Time Frame: up to <span class="drop_hilite">39 </span> <span
|
|
class="add_hilite">43 </span>months ]<br><br><span class="add_hilite">OS
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="white-space:nowrap;width: 3em;">Secondary Outcome Measures:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">1.</td>
|
|
<td>Complete remission with duration<br>[ Time Frame: <span class="drop_hilite">Up </span> <span
|
|
class="add_hilite">up </span>to <span class="drop_hilite">39 </span> <span
|
|
class="add_hilite">43 </span>months ]<br><br><span class="add_hilite">CR with duration
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">2.</td>
|
|
<td>Complete remission with incomplete platelet count recovery and duration<br>[ Time Frame: up
|
|
to <span class="drop_hilite">39 </span> <span class="add_hilite">43 </span>months
|
|
]<br><br><span class="add_hilite">CRp with duration
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">3.</td>
|
|
<td>Partial remission with duration<br>[ Time Frame: up to <span class="drop_hilite">39 </span>
|
|
<span class="add_hilite">43 </span>months ]<br><br><span class="add_hilite">PR with duration
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">4.</td>
|
|
<td>Hematological improvement with duration<br>[ Time Frame: up to <span class="drop_hilite">39
|
|
</span> <span class="add_hilite">43 </span>months ]<br><br><span class="add_hilite">HI with
|
|
duration
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">5.</td>
|
|
<td>Stable disease with duration<br>[ Time Frame: up to <span class="drop_hilite">39 </span>
|
|
<span class="add_hilite">43 </span>months ]<br><br><span class="add_hilite">SD with duration
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">6.</td>
|
|
<td>Number of units of blood product transfused<br>[ Time Frame: up to <span
|
|
class="drop_hilite">39 </span> <span class="add_hilite">43 </span>months ]<br><br> </td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">7.</td>
|
|
<td>Hospitalized days<br>[ Time Frame: up to <span class="drop_hilite">39 </span> <span
|
|
class="add_hilite">43 </span>months ]<br><br> </td>
|
|
</tr>
|
|
<tr style="vertical-align:top;">
|
|
<td class="rowLabel" style="width:3em;white-space:nowrap;">8.</td>
|
|
<td>1-year survival<br>[ Time Frame: up to <span class="drop_hilite">39 </span> <span
|
|
class="add_hilite">43 </span>months ]<br><br><span class="add_hilite">In %
|
|
</span>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_Eligibility">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="Eligibility"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="EligibilityImg" class="toggleImage"
|
|
onclick="toggleModule('Eligibility');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Eligibility</legend>
|
|
<div id="EligibilityBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Minimum Age:</td>
|
|
<td>70 Years </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Maximum Age:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Sex:</td>
|
|
<td>All </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Gender Based:</td>
|
|
<td></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Accepts Healthy Volunteers:</td>
|
|
<td>No</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Criteria:</td>
|
|
<td>
|
|
<p>Inclusion Criteria:</p>
|
|
<ul>
|
|
<li>Newly diagnosed AML based on WHO <span class="add_hilite">(World Health Organization)
|
|
</span>classification</li>
|
|
<li>Age 70 years or older for whom the treatment of choice is low-intensity therapy by
|
|
investigator assessment or who has refused intensive induction therapy recommended by
|
|
investigator</li>
|
|
<li>ECOG <span class="add_hilite">(Eastern Cooperative Oncology Group) </span>performance
|
|
status 0-2</li>
|
|
<li>Adequate renal function</li>
|
|
<li>Adequate liver function</li>
|
|
<li>Able to swallow capsules</li>
|
|
<li>Agree to practice effective contraception</li>
|
|
<li>Ability to understand and willingness to sign the informed consent form</li>
|
|
</ul>
|
|
<p>Exclusion Criteria:</p>
|
|
<ul>
|
|
<li>AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor
|
|
without bone marrow involvement</li>
|
|
<li>Having received any systemic anti-cancer therapy for AML or received treatment with
|
|
hypomethylating agents or cytotoxic chemotherapy for <span class="drop_hilite">the </span>
|
|
preceding <span class="drop_hilite">MDS </span> <span class="add_hilite">myelodysplastic
|
|
syndrome (MDS) </span>or <span class="add_hilite">myeloproliferative disease
|
|
(</span>MPD<span class="add_hilite">)</span></li>
|
|
<li>Known or suspected central nervous system (CNS) involvement by leukemia</li>
|
|
<li>Uncontrolled intercurrent illness</li>
|
|
<li>Known hypersensitivity to decitabine</li>
|
|
<li>Known to be HIV-positive</li>
|
|
</ul>
|
|
</td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_ContactsLocations">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="ContactsLocations"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="ContactsLocationsImg" class="toggleImage"
|
|
onclick="toggleModule('ContactsLocations');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
Contacts/Locations</legend>
|
|
<div id="ContactsLocationsBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Central Contact Person:</td>
|
|
<td><span class="drop_hilite">Judy H Chiao, MD<br><span class="indent1">Telephone:
|
|
908-517-7330</span><br><span class="indent1">Email: jchiao@cyclacel.com</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Study Officials:</td>
|
|
<td> <span class="add_hilite">Hagop M Kantarjian, M.D.</span><br> <span class="add_hilite">Study
|
|
Chair</span><br> <span class="add_hilite">M.D. Anderson Cancer Center</span> </td>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Locations:</td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Alabama</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">University of Alabama Comprehensive Cancer Center<br><span
|
|
class="indent1">Birmingham, Alabama, United States, 35294</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
California</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Scripps Cancer Center<br><span class="indent1">La Jolla,
|
|
California, United States, 92037</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">UCLA Ronald Reagan Medical Center<br><span class="indent1">Los
|
|
Angeles, California, United States, 90095</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Connecticut</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Norwalk Hospital<br><span class="indent1">Norwalk, Connecticut,
|
|
United States, 06850</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span class="drop_hilite"><span style="font-weight:bold;">United States,
|
|
Connecticut</span></span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span class="drop_hilite">Cancer Center of Central Connecticut<br>[Recruiting]<br><span
|
|
class="indent1">Southington, Connecticut, United States, 06489</span><br><span
|
|
class="indent1"><span style="margin-right:3em;">Contact:</span>Contact: Mark Turney
|
|
860-621-9316 </span><br><span class="indent1"><span
|
|
style="margin-right:3em;">Contact:</span>Principal Investigator: Peter Byeff, MD
|
|
</span></span> </td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Florida</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Shands Cancer Hospital at University of Florida<br><span
|
|
class="indent1">Gainesville, Florida, United States, 32608</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Cleveland Clinic Florida<br><span class="indent1">Weston, Florida,
|
|
United States, 33331</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Georgia</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Winship Cancer Institute, Emory University<br><span
|
|
class="indent1">Atlanta, Georgia, United States, 30322</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Blood and Marrow Transplant Group of Georgia<br><span
|
|
class="indent1">Atlanta, Georgia, United States, 30342</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span style="font-weight:bold;">United States, Illinois</span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span class="drop_hilite">The University of Chicago Medical Center<br>[Recruiting]<br><span
|
|
class="indent1">Chicago, Illinois, United States, 60637</span><br><span
|
|
class="indent1"><span style="margin-right:3em;">Contact:</span>Contact: Margaret Green, RN
|
|
773-702-0267 </span><br><span class="indent1"><span
|
|
style="margin-right:3em;">Contact:</span>Principal Investigator: Wendy Stock, MD
|
|
</span></span> <span class="add_hilite">Northwestern Memorial Hospital<br><span
|
|
class="indent1">Chicago, Illinois, United States, 60611</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Rush University Medical Center<br><span class="indent1">Chicago,
|
|
Illinois, United States, 60612</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">The University of Chicago Medical Center<br><span
|
|
class="indent1">Chicago, Illinois, United States, 60637</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Indiana</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">St. Francis Medical Group Oncology and Hematology
|
|
Specialists<br><span class="indent1">Indianapolis, Indiana, United States,
|
|
46237</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Iowa</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">University of Iowa Hospitals and Clinics<br><span
|
|
class="indent1">Iowa City, Iowa, United States, 52242</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Maryland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">University of Maryland Greenbaum Cancer Center<br><span
|
|
class="indent1">Baltimore, Maryland, United States, 21201</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Massachusetts</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Beth Israel Deaconess Medical Center<br><span
|
|
class="indent1">Boston, Massachusetts, United States, 02215</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Michigan</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Henry Ford Health System<br><span class="indent1">Detroit,
|
|
Michigan, United States, 48202</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Minnesota</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Mayo Clinic<br><span class="indent1">Rochester, Minnesota, United
|
|
States, 55905</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Missouri</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Saint Luke's Cancer Institute<br><span class="indent1">Kansas
|
|
City, Missouri, United States, 64111</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">St. Louis University Cancer Center<br><span class="indent1">Saint
|
|
Louis, Missouri, United States, 63110</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Nebraska</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">University of Nebraska Medical Center<br><span
|
|
class="indent1">Omaha, Nebraska, United States, 68198</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, New
|
|
Hampshire</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Dartmouth - Hitchcock Medical Center<br><span
|
|
class="indent1">Lebanon, New Hampshire, United States, 03756</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, New
|
|
Jersey</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">John Theurer Cancer Center at the Hackensack University Medical
|
|
Center<br><span class="indent1">Hackensack, New Jersey, United States, 07601</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, New
|
|
York</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Westchester Hematology Oncology Group, PC<br><span
|
|
class="indent1">Hawthorne, New York, United States, 10532</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Beth Israel Medical Center<br><span class="indent1">New York, New
|
|
York, United States, 10003</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Memorial Sloan Kettering Cancer Center<br><span
|
|
class="indent1">New York, New York, United States, 10065</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Stony Brook University Medical Center<br><span
|
|
class="indent1">Stony Brook, New York, United States, 11794</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, North
|
|
Carolina</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Duke University Medical Center<br><span class="indent1">Durham,
|
|
North Carolina, United States, 27710</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Ohio</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Gabrail Cancer Center Research<br><span class="indent1">Canton,
|
|
Ohio, United States, 44718</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">University of Cincinnati<br><span class="indent1">Cincinnati,
|
|
Ohio, United States, 45267</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Cleveland Clinic Foundation<br><span class="indent1">Cleveland,
|
|
Ohio, United States, 44195</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Pennsylvania</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Penn State Milton S. Hershey Medical Center<br><span
|
|
class="indent1">Hershey, Pennsylvania, United States, 17033</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Abramson Cancer Center of the University of Pennsylvania<br><span
|
|
class="indent1">Philadelphia, Pennsylvania, United States, 19104</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, South
|
|
Carolina</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Saint Francis Hospital<br><span class="indent1">Greenville, South
|
|
Carolina, United States, 29601</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Tennessee</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Vanderbilt University Medical Center<br><span
|
|
class="indent1">Nashville, Tennessee, United States, 37232</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Texas</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Baylor University Medical Center<br><span class="indent1">Dallas,
|
|
Texas, United States, 75246</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span class="drop_hilite"><span style="font-weight:bold;">United States, Texas</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td><span class="drop_hilite">MD Anderson Cancer Center<br>[Recruiting]<br><span
|
|
class="indent1">Houston, Texas, United States, 77030-3387</span><br><span
|
|
class="indent1"><span style="margin-right:3em;">Contact:</span>Contact: Patricia Boone, RN
|
|
713-792-9191 </span><br><span class="indent1"><span
|
|
style="margin-right:3em;">Contact:</span>Principal Investigator: Hagop Kantarjian, MD
|
|
</span></span> <span class="add_hilite">MD Anderson Cancer Center<br><span
|
|
class="indent1">Houston, Texas, United States, 77030-3387</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Joe Arrington Cancer Research and Treatment Center<br><span
|
|
class="indent1">Lubbock, Texas, United States, 79410</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States, Utah</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Huntsman Cancer Institute at the University of Utah<br><span
|
|
class="indent1">Salt Lake City, Utah, United States, 84112</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United States,
|
|
Wisconsin</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">The Medical College of Wisconsin<br><span
|
|
class="indent1">Milwaukee, Wisconsin, United States, 53226</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Austria</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Medizinische Universitaetsklinik<br><span
|
|
class="indent1">Innsbruck, Austria</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Elisabethinen Krankenhaus<br><span class="indent1">Linz,
|
|
Austria</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Krankenhaus der Barmherzigen Schwestern<br><span
|
|
class="indent1">Linz, Austria</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Univ. Klinik fur Innere Medizin III LKH<br><span
|
|
class="indent1">Salzburg, Austria</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Klinikum Wels-Grieskirchen GmbH<br><span class="indent1">Wels,
|
|
Austria</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AKH Wien<br><span class="indent1">Wien, Austria</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hanusch Krankenhaus<br><span class="indent1">Wien,
|
|
Austria</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Belgium</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Ziekenhuis Netwerk Antwerpen Stuivenberg<br><span
|
|
class="indent1">Antwerpen, Belgium</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AZ Sint-Jan Brugge-Oostende<br><span class="indent1">Brugge,
|
|
Belgium</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Universite Catholique de Louvain<br><span
|
|
class="indent1">Brussels, Belgium</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Centre Hospitalier De Jolimont-Lobbes<br><span class="indent1">La
|
|
Louviere, Belgium</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Cliniques Universitaires UCL de Mont-Godinne<br><span
|
|
class="indent1">Yvoir, Belgium</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">CHU d'Amiens Hopital Sud<br><span class="indent1">Amiens,
|
|
France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Centre Hospitalier de la Cote Basque<br><span
|
|
class="indent1">Bayonne, France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">CHU de Lyon - Hopital Edouard Herriot<br><span
|
|
class="indent1">Lyon, France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Institut Paoli Calmettes<br><span class="indent1">Marseille,
|
|
France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">CHRU De Montpellier Hopital St. Eloi<br><span
|
|
class="indent1">Montpellier, France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Centre Hospitalier De Mulhouse<br><span class="indent1">Mulhouse,
|
|
France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hopital St Louis Universite Paris 7<br><span
|
|
class="indent1">Paris, France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Centre Hospitalier de Perigueux<br><span
|
|
class="indent1">Perigueux, France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Centre Hospitalier d'Annecy<br><span class="indent1">Pringy,
|
|
France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Centre Hospitalier de Saint-Brieuc Yves Ie Foll<br><span
|
|
class="indent1">St Brieuc, France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">CHU de Strasbourg - Hopital Civil<br><span
|
|
class="indent1">Strasbourg, France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Strasbourg Oncologie Liberale<br><span class="indent1">Strasbourg,
|
|
France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">CHU de Tours Hopital Bretonneau<br><span class="indent1">Tours,
|
|
France</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Universitaetsklinikum Charite Berlin, Campus Benjamin
|
|
Franklin<br><span class="indent1">Berlin, Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Universitaetsklinikum Carl-Gustav-Carus Dresden<br><span
|
|
class="indent1">Dresden, Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">St. Johannes Hospital<br><span class="indent1">Duisburg,
|
|
Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Klinikum Frankfurt Hoechst<br><span class="indent1">Frankfurt,
|
|
Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Asklepios Klinik Altona<br><span class="indent1">Hamburg,
|
|
Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Medizinische Hochschule Hannover<br><span
|
|
class="indent1">Hannover, Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">SLK Kliniken Heilbronn<br><span class="indent1">Heilbronn,
|
|
Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Klinikum St. Georg<br><span class="indent1">Leipzig,
|
|
Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Johannes Wesling Klinikum<br><span class="indent1">Minden,
|
|
Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">TU Muenchen<br><span class="indent1">Muenchen,
|
|
Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Universitaetsklinikum Muenster<br><span class="indent1">Muenster,
|
|
Germany</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Hungary</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">University of Debrecen<br><span class="indent1">Debrecen,
|
|
Hungary</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Petz Aladar Megyei Oktato Korhaz<br><span class="indent1">Győr,
|
|
Hungary</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Kaposi Mor Oktato Korhaz<br><span class="indent1">Kaposvár,
|
|
Hungary</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AOU Ospedali Riuniti Umberto I<br><span class="indent1">Ancona,
|
|
Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AO Ospedali Riuniti di Bergamo<br><span class="indent1">Bergamo,
|
|
Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Universita di Bologna Ist Ematologia Oncologia Medica
|
|
Seragnoli<br><span class="indent1">Bologna, Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AO Spedali Civili di Brescia<br><span class="indent1">Brescia,
|
|
Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Universita Cattolica del Sacro Cuore<br><span
|
|
class="indent1">Campobasso, Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AOU Careggi<br><span class="indent1">Firenze, Italy</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AOU San Martino IST<br><span class="indent1">Genova,
|
|
Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">PO Vito Fazzi<br><span class="indent1">Lecce, Italy</span></span>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Ospedale San Raffaele<br><span class="indent1">Milano,
|
|
Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AORN Antonio Cardarelli<br><span class="indent1">Napoli,
|
|
Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Uni. Napoli Ospedale Federico lI<br><span class="indent1">Napoli,
|
|
Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AOU Maggiore della Carità di Novara<br><span
|
|
class="indent1">Novara, Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AOOR Villa Sofia Cervello di Palermo<br><span
|
|
class="indent1">Palermo, Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Policlinico San Matteo Di Pavia<br><span class="indent1">Pavia,
|
|
Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">AOU San Luigi Gonzaga<br><span class="indent1">Torino,
|
|
Italy</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Poland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Akademickie Centrum Kliniczne Szpital Akademii Medycznej w
|
|
Gdansku<br><span class="indent1">Gdansk, Poland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Wojewodzki Szpital Specjalistyczny<br><span
|
|
class="indent1">Legnica, Poland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Wojewódzki Szpital Specjalistyczny w Legnicy<br><span
|
|
class="indent1">Legnica, Poland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">University of Lodz N. Copernicus Memorial Hospital<br><span
|
|
class="indent1">Lodz, Poland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">IHT Instytut Hematologii I Transfuzjologii w Warszawie<br><span
|
|
class="indent1">Warsaw, Poland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu<br><span
|
|
class="indent1">Wroclaw, Poland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Universitari Germans Trias i Pujol ICO Badalona<br><span
|
|
class="indent1">Badalona, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Clinic de Barcelona<br><span class="indent1">Barcelona,
|
|
Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital De La Santa Creu Sant Pau<br><span
|
|
class="indent1">Barcelona, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Universitario Vall d'Hebron<br><span
|
|
class="indent1">Barcelona, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Universitario de Canarias<br><span class="indent1">La
|
|
Laguna, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Universitario Ramon y Cajal<br><span
|
|
class="indent1">Madrid, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">MD Anderson Cancer Center<br><span class="indent1">Madrid,
|
|
Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Son Llatzer<br><span class="indent1">Palma de Mallorca,
|
|
Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Universitari Son Espases<br><span class="indent1">Palma
|
|
de Mallorca, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Clínica Universidad de Navarra<br><span class="indent1">Pamplona,
|
|
Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Complejo Hospitalario de Navarra<br><span
|
|
class="indent1">Pamplona, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Clinico Universitario de Salamanca<br><span
|
|
class="indent1">Salamanca, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Clinico Universitario<br><span class="indent1">Santiago
|
|
de Compostela, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Universitario Virgen del Rocio<br><span
|
|
class="indent1">Sevilla, Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Hospital Universitari "La Fe"<br><span class="indent1">Valencia,
|
|
Spain</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Sweden</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Sunderby Hospital<br><span class="indent1">Luleå,
|
|
Sweden</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Skåne Universitetssjukhus Univ Hospital Lund<br><span
|
|
class="indent1">Lund, Sweden</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">Switzerland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Inselspital Bern<br><span class="indent1">Bern,
|
|
Switzerland</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite"><span style="font-weight:bold;">United Kingdom</span></span></td>
|
|
</tr>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;"></td>
|
|
<td> <span class="add_hilite">Kings College Hospital and Guys and St Thomas' Hospital<br><span
|
|
class="indent1">London, United Kingdom</span></span></td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_IPDSharing">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="IPDSharing"
|
|
style="margin:auto;margin-bottom:1em;padding-bottom:0.5em;width:98%;">
|
|
<legend class="moduleLabel"> <img id="IPDSharingImg" class="toggleImage"
|
|
onclick="toggleModule('IPDSharing');" src="html/images/collapse.png"
|
|
alt='Open or close this module'>
|
|
IPDSharing</legend>
|
|
<div id="IPDSharingBody" class="moduleBody">
|
|
<table class="indent1 moduleTable resultTable">
|
|
<thead>
|
|
<tr>
|
|
<th style="width:210px;"></th>
|
|
<th></th>
|
|
</tr>
|
|
</thead>
|
|
<tbody>
|
|
<tr>
|
|
<td class="rowLabel" style="min-width: 210px;">Plan to Share IPD:</td>
|
|
<td> <span class="add_hilite">No</span> </td>
|
|
</tr>
|
|
</tbody>
|
|
</table>
|
|
</div>
|
|
</fieldset>
|
|
</div>
|
|
</form>
|
|
</td>
|
|
</tr>
|
|
<tr>
|
|
<td colspan="2">
|
|
<form id="form_References">
|
|
<div class="w3-responsive">
|
|
<fieldset class="entryReq" id="References"
|
|
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<td> <span class="add_hilite"><span style="font-weight:bold">[Study Results]</span> Kantarjian,
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H.M.; Begna, K.H.; Altman, J.K.; Goldberg, S.L.; Sekeres, M.A.; Strickland, S.A.;
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Rubenstein, S.E.; Arellano, M.L.; Claxton, D.F.; Baer, M.R.; et al. Results of a Phase 3
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Study of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine
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Administered in Alternating Cycles. Blood 2017, vol. 130 no. Suppl 1 891.
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http://www.bloodjournal.org/content/130/Suppl_1/891.</span></td>
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