History of Changes for Study: NCT01303796

Version	A	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

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:

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]

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.

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

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

Primary Outcome Measures:

Overall survival
[ Time Frame: up to 39 43 months ]

OS

Secondary Outcome Measures:

Complete remission with duration
[ Time Frame: Up up to 39 43 months ]

CR with duration

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

CRp with duration

Partial remission with duration
[ Time Frame: up to 39 43 months ]

PR with duration

Hematological improvement with duration
[ Time Frame: up to 39 43 months ]

HI with duration

Stable disease with duration
[ Time Frame: up to 39 43 months ]

SD with duration

Number of units of blood product transfused
[ Time Frame: up to 39 43 months ]

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

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

In %

Minimum Age:

70 Years

Maximum Age:

Sex:

All

Gender Based:

Accepts Healthy Volunteers:

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

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: