# History of Changes for Study: NCT01303796

History of Changes for Study: NCT01303796
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS)
Latest version (submitted October 28, 2018) on ClinicalTrials.gov

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Study Record Versions

Version | A | B | Submitted Date | Changes
--- | --- | --- | --- | ---
1 |  |  | February 24, 2011 | None (earliest Version on record)
2 |  |  | March 23, 2011 | Contacts/Locations and Study Status
3 |  |  | April 11, 2011 | Contacts/Locations and Study Status
4 |  |  | November 7, 2011 | Sponsor/Collaborators, Study Status, Contacts/Locations and Oversight
5 |  |  | May 2, 2012 | Study Status, Outcome Measures, Arms and Interventions, Study Description, Contacts/Locations and Study Design
6 |  |  | May 3, 2012 | Contacts/Locations and Study Status
7 |  |  | May 4, 2012 | Contacts/Locations and Study Status
8 |  |  | May 7, 2012 | Contacts/Locations and Study Status
9 |  |  | May 14, 2012 | Contacts/Locations and Study Status
10 |  |  | July 11, 2012 | Contacts/Locations and Study Status
11 |  |  | September 25, 2012 | Study Status and Contacts/Locations
12 |  |  | December 14, 2012 | Contacts/Locations and Study Status
13 |  |  | November 14, 2013 | Contacts/Locations and Study Status
14 |  |  | February 10, 2014 | Contacts/Locations and Study Status
15 |  |  | March 25, 2014 | Contacts/Locations and Study Status
16 |  |  | September 8, 2014 | Contacts/Locations and Study Status
17 |  |  | April 13, 2015 | Recruitment Status, Study Status and Contacts/Locations
18 |  |  | August 17, 2015 | Contacts/Locations and Study Status
19 |  |  | October 18, 2018 | Recruitment Status, Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations, Study Design, Study Description, Oversight, IPDSharing, References and Eligibility
20 |  |  | October 28, 2018 | Arms and Interventions and Study Status
| Results Submission Events
December 7, 2021 March 23, 2022 | Returned after QC review: January 4, 2022 Returned after QC review: April 20, 2022

Comparison Format:

- Merged
- Side-by-Side

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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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Study Identification

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: |

Study Status

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]

Sponsor/Collaborators

Sponsor: | Cyclacel Pharmaceuticals, Inc.
Responsible Party: | Sponsor
Collaborators: |

Oversight

U.S. FDA-regulated Drug: | Yes
U.S. FDA-regulated Device: | No
Data Monitoring: | Yes

Study Description

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.

Conditions

Conditions: | Acute Myeloid Leukemia
Keywords: | AML

Study Design

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]

Arms and Interventions

Arms | Assigned 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

Outcome Measures

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 %

Eligibility

Minimum Age: | 70 Years
Maximum Age: |
Sex: | All
Gender Based: |
Accepts Healthy Volunteers: | No

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Contacts/Locations

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

IPDSharing

Plan to Share IPD: | No

References

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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