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History of Changes for Study: NCT01303796
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A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS)
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Latest version (submitted October 28, 2018) on ClinicalTrials.gov
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Study Record Versions + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
VersionABSubmitted DateChanges
1February 24, 2011 +None (earliest Version on record)
2March 23, 2011 +Contacts/Locations and Study Status
3April 11, 2011 +Contacts/Locations and Study Status
4November 7, 2011 +Sponsor/Collaborators, Study Status, Contacts/Locations and Oversight
5May 2, 2012 +Study Status, Outcome Measures, Arms and Interventions, Study Description, Contacts/Locations and Study Design
6May 3, 2012 +Contacts/Locations and Study Status
7May 4, 2012 +Contacts/Locations and Study Status
8May 7, 2012 +Contacts/Locations and Study Status
9May 14, 2012 +Contacts/Locations and Study Status
10July 11, 2012 +Contacts/Locations and Study Status
11September 25, 2012 +Study Status and Contacts/Locations
12December 14, 2012 +Contacts/Locations and Study Status
13November 14, 2013 +Contacts/Locations and Study Status
14February 10, 2014 +Contacts/Locations and Study Status
15March 25, 2014 +Contacts/Locations and Study Status
16September 8, 2014 +Contacts/Locations and Study Status
17April 13, 2015 +Recruitment Status, Study Status and Contacts/Locations
18August 17, 2015 +Contacts/Locations and Study Status
19October 18, 2018 +Recruitment Status, Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations, Study Design, Study Description, Oversight, IPDSharing, References and Eligibility
20October 28, 2018 +Arms and Interventions and Study Status
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Results Submission Events
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+Changes (Merged) for Study: NCT01303796
+February 24, 2011 (v1) -- October 28, 2018 (v20)

Changes in: Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing, References +
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Unique Protocol ID:CYC682-12
Brief Title:A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS)
Official Title:A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Secondary IDs:
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Record Verification:February 2011 October 2018
Overall Status:Recruiting Completed
Study Start:January 2011 October 1, 2011
Primary Completion:September 2013 [Anticipated] December 15, 2016 [Actual]
Study Completion:March 2014 [Anticipated] July 31, 2017 [Actual]
First Submitted:February 21, 2011
First Submitted that
Met QC Criteria:		February 24, 2011
First Posted:February 25, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:		February 24, 2011 October 28, 2018
Last Update Posted:February 25, 2011 [Estimate] October 31, 2018 [Actual]
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Sponsor:Cyclacel Pharmaceuticals, Inc.
Responsible Party: Sponsor
Collaborators:
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U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
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Brief Summary:This Phase 3 study assesses three two 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 three two drug regimens are sapacitabine administered in alternating cycles with decitabine, sapacitabine alone or decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.
Detailed Description:This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing three two 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, in Arm B sapacitabine is administered alone 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 either of two pairwise comparisons: (1) Arm A versus Arm C or (2) Arm B versus Arm C.
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Conditions:Acute Myeloid Leukemia
Keywords:AML
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Study Type:Interventional
Primary Purpose:Treatment
Study Phase:Phase 3
Interventional Study Model:Parallel Assignment
Number of Arms:3 2
Masking:None (Open Label)
Allocation:Randomized
Enrollment:470 [Anticipated] 482 [Actual]
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ArmsAssigned Interventions
Experimental: Arm A Experimental: Sapacitabine-decitabine alternating
Sapacitabine and decitabine Arm A sapacitabine administered in alternating cycles with decitabine
Drug: Sapacitabine and decitabine Drug: Sapacitabine
Sapacitabine administered in alternating cycles with decitabine oral sapacitabine capsules
Drug: Decitabine
decitabine intravenous + +
Active Comparator: Arm B
Sapacitabine + +
Drug: Sapacitabine
Sapacitabine alone + +
Active Comparator: Arm C Decitabine
Arm C Decitabine
Drug: Decitabine
Decitabine alone decitabine intravenous
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Primary Outcome Measures:
1.Overall survival
[ Time Frame: up to 39 43 months ]

OS + +
Secondary Outcome Measures:
1.Complete remission with duration
[ Time Frame: Up up to 39 43 months ]

CR with duration + +
2.Complete remission with incomplete platelet count recovery and duration
[ Time Frame: up to 39 43 months ]

CRp with duration + +
3.Partial remission with duration
[ Time Frame: up to 39 43 months ]

PR with duration + +
4.Hematological improvement with duration
[ Time Frame: up to 39 43 months ]

HI with duration + +
5.Stable disease with duration
[ Time Frame: up to 39 43 months ]

SD with duration + +
6.Number of units of blood product transfused
[ Time Frame: up to 39 43 months ]

7.Hospitalized days
[ Time Frame: up to 39 43 months ]

8.1-year survival
[ Time Frame: up to 39 43 months ]

In % + +
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Minimum Age:70 Years
Maximum Age:
Sex:All
Gender Based:
Accepts Healthy Volunteers:No
Criteria:

Inclusion Criteria:

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  • Newly diagnosed AML based on WHO (World Health Organization) classification
  • 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
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2
  • Adequate renal function
  • Adequate liver function
  • Able to swallow capsules
  • Agree to practice effective contraception
  • Ability to understand and willingness to sign the informed consent form
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Exclusion Criteria:

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  • AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
  • Having received any systemic anti-cancer therapy for AML or received treatment with hypomethylating agents or cytotoxic chemotherapy for the preceding MDS myelodysplastic syndrome (MDS) or myeloproliferative disease (MPD)
  • Known or suspected central nervous system (CNS) involvement by leukemia
  • Uncontrolled intercurrent illness
  • Known hypersensitivity to decitabine
  • Known to be HIV-positive
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Central Contact Person:Judy H Chiao, MD
Telephone: 908-517-7330
Email: jchiao@cyclacel.com
Study Officials: Hagop M Kantarjian, M.D.
Study Chair
M.D. Anderson Cancer Center
Locations: United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
Scripps Cancer Center
La Jolla, California, United States, 92037
UCLA Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06850
United States, Connecticut
Cancer Center of Central Connecticut
[Recruiting]
Southington, Connecticut, United States, 06489
Contact:Contact: Mark Turney 860-621-9316
Contact:Principal Investigator: Peter Byeff, MD
United States, Florida
Shands Cancer Hospital at University of Florida
Gainesville, Florida, United States, 32608
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
The University of Chicago Medical Center
[Recruiting]
Chicago, Illinois, United States, 60637
Contact:Contact: Margaret Green, RN 773-702-0267
Contact:Principal Investigator: Wendy Stock, MD Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, United States, 46237
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
St. Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
John Theurer Cancer Center at the Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Westchester Hematology Oncology Group, PC
Hawthorne, New York, United States, 10532
Beth Israel Medical Center
New York, New York, United States, 10003
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Texas
MD Anderson Cancer Center
[Recruiting]
Houston, Texas, United States, 77030-3387
Contact:Contact: Patricia Boone, RN 713-792-9191
Contact:Principal Investigator: Hagop Kantarjian, MD MD Anderson Cancer Center
Houston, Texas, United States, 77030-3387
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
United States, Utah
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Austria
Medizinische Universitaetsklinik
Innsbruck, Austria
Elisabethinen Krankenhaus
Linz, Austria
Krankenhaus der Barmherzigen Schwestern
Linz, Austria
Univ. Klinik fur Innere Medizin III LKH
Salzburg, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria
AKH Wien
Wien, Austria
Hanusch Krankenhaus
Wien, Austria
Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerpen, Belgium
AZ Sint-Jan Brugge-Oostende
Brugge, Belgium
Universite Catholique de Louvain
Brussels, Belgium
Centre Hospitalier De Jolimont-Lobbes
La Louviere, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium
France
CHU d'Amiens Hopital Sud
Amiens, France
Centre Hospitalier de la Cote Basque
Bayonne, France
CHU de Lyon - Hopital Edouard Herriot
Lyon, France
Institut Paoli Calmettes
Marseille, France
CHRU De Montpellier Hopital St. Eloi
Montpellier, France
Centre Hospitalier De Mulhouse
Mulhouse, France
Hopital St Louis Universite Paris 7
Paris, France
Centre Hospitalier de Perigueux
Perigueux, France
Centre Hospitalier d'Annecy
Pringy, France
Centre Hospitalier de Saint-Brieuc Yves Ie Foll
St Brieuc, France
CHU de Strasbourg - Hopital Civil
Strasbourg, France
Strasbourg Oncologie Liberale
Strasbourg, France
CHU de Tours Hopital Bretonneau
Tours, France
Germany
Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin
Berlin, Germany
Universitaetsklinikum Carl-Gustav-Carus Dresden
Dresden, Germany
St. Johannes Hospital
Duisburg, Germany
Klinikum Frankfurt Hoechst
Frankfurt, Germany
Asklepios Klinik Altona
Hamburg, Germany
Medizinische Hochschule Hannover
Hannover, Germany
SLK Kliniken Heilbronn
Heilbronn, Germany
Klinikum St. Georg
Leipzig, Germany
Johannes Wesling Klinikum
Minden, Germany
TU Muenchen
Muenchen, Germany
Universitaetsklinikum Muenster
Muenster, Germany
Hungary
University of Debrecen
Debrecen, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, Hungary
Kaposi Mor Oktato Korhaz
Kaposvár, Hungary
Italy
AOU Ospedali Riuniti Umberto I
Ancona, Italy
AO Ospedali Riuniti di Bergamo
Bergamo, Italy
Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli
Bologna, Italy
AO Spedali Civili di Brescia
Brescia, Italy
Universita Cattolica del Sacro Cuore
Campobasso, Italy
AOU Careggi
Firenze, Italy
AOU San Martino IST
Genova, Italy
PO Vito Fazzi
Lecce, Italy
Ospedale San Raffaele
Milano, Italy
AORN Antonio Cardarelli
Napoli, Italy
Uni. Napoli Ospedale Federico lI
Napoli, Italy
AOU Maggiore della Carità di Novara
Novara, Italy
AOOR Villa Sofia Cervello di Palermo
Palermo, Italy
Policlinico San Matteo Di Pavia
Pavia, Italy
AOU San Luigi Gonzaga
Torino, Italy
Poland
Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku
Gdansk, Poland
Wojewodzki Szpital Specjalistyczny
Legnica, Poland
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica, Poland
University of Lodz N. Copernicus Memorial Hospital
Lodz, Poland
IHT Instytut Hematologii I Transfuzjologii w Warszawie
Warsaw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu
Wroclaw, Poland
Spain
Hospital Universitari Germans Trias i Pujol ICO Badalona
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital De La Santa Creu Sant Pau
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Canarias
La Laguna, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Son Llatzer
Palma de Mallorca, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, Spain
Hospital Clinico Universitario
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain
Hospital Universitari "La Fe"
Valencia, Spain
Sweden
Sunderby Hospital
Luleå, Sweden
Skåne Universitetssjukhus Univ Hospital Lund
Lund, Sweden
Switzerland
Inselspital Bern
Bern, Switzerland
United Kingdom
Kings College Hospital and Guys and St Thomas' Hospital
London, United Kingdom
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Plan to Share IPD: No
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Citations: [Study Results] Kantarjian, H.M.; Begna, K.H.; Altman, J.K.; Goldberg, S.L.; Sekeres, M.A.; Strickland, S.A.; Rubenstein, S.E.; Arellano, M.L.; Claxton, D.F.; Baer, M.R.; et al. Results of a Phase 3 Study of Elderly Patients with Newly Diagnosed AML Treated with Sapacitabine and Decitabine Administered in Alternating Cycles. Blood 2017, vol. 130 no. Suppl 1 891. http://www.bloodjournal.org/content/130/Suppl_1/891.
Links:
Available IPD/Information:
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