A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
SEAMLESS
A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
1 other identifier
interventional
482
12 countries
118
Brief Summary
This Phase 3 study assesses 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 two drug regimens are sapacitabine administered in alternating cycles with 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2011
Longer than P75 for phase_3
118 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedResults Posted
Study results publicly available
June 22, 2022
CompletedJune 22, 2022
May 1, 2022
5.2 years
February 21, 2011
December 7, 2021
May 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
The distribution of overall survival was estimated by the method of Kaplan and Meier. A log-rank analysis stratified by randomization stratification factors was used to compare overall survival between Arm A (decitabine/sapacitabine) versus Arm C (decitabine). Cox proportional hazards models were used to identify predictive factors for overall survival.
up to 43 months
Secondary Outcomes (13)
Complete Remission (CR)
up to 43 months
Complete Remission With Incomplete Platelet Count Recovery (CRp)
up to 43 months
Partial Remission (PR)
up to 43 months
Hematological Improvement
up to 43 months
Stable Disease (SD)
up to 43 months
- +8 more secondary outcomes
Study Arms (2)
Sapacitabine-decitabine alternating
EXPERIMENTALArm A sapacitabine administered in alternating cycles with decitabine
Decitabine
ACTIVE COMPARATORArm C Decitabine
Interventions
Decitabine intravenous
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 preceding 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (118)
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Scripps Cancer Center
La Jolla, California, 92037, United States
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095, United States
Norwalk Hospital
Norwalk, Connecticut, 06850, United States
Shands Cancer Hospital at University of Florida
Gainesville, Florida, 32608, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
St. Francis Medical Group Oncology and Hematology Specialists
Indianapolis, Indiana, 46237, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, 21201, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
St. Louis University Cancer Center
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
John Theurer Cancer Center at the Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Westchester Hematology Oncology Group, PC
Hawthorne, New York, 10532, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center
Houston, Texas, 77030-3387, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Medizinische Universitaetsklinik
Innsbruck, Austria
Elisabethinen Krankenhaus
Linz, Austria
Krankenhaus der Barmherzigen Schwestern
Linz, Austria
Univ. Klinik fur Innere Medizin III LKH
Salzburg, Austria
AKH Wien
Vienna, Austria
Hanusch Krankenhaus
Vienna, Austria
Klinikum Wels-Grieskirchen GmbH
Wels, Austria
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, Belgium
AZ Sint-Jan Brugge-Oostende
Bruges, Belgium
Universite Catholique de Louvain
Brussels, Belgium
Centre Hospitalier De Jolimont-Lobbes
La Louvière, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Belgium
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
Périgueux, France
Centre Hospitalier d'Annecy
Pringy, France
Centre Hospitalier de Saint-Brieuc Yves Ie Foll
Saint-Brieuc, France
CHU de Strasbourg - Hopital Civil
Strasbourg, France
Strasbourg Oncologie Liberale
Strasbourg, France
CHU de Tours Hopital Bretonneau
Tours, France
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
Hanover, Germany
SLK Kliniken Heilbronn
Heilbronn, Germany
Klinikum St. Georg
Leipzig, Germany
Johannes Wesling Klinikum
Minden, Germany
TU Muenchen
München, Germany
Universitaetsklinikum Muenster
Münster, Germany
University of Debrecen
Debrecen, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, Hungary
Kaposi Mor Oktato Korhaz
Kaposvár, Hungary
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
Florence, Italy
AOU San Martino IST
Genova, Italy
PO Vito Fazzi
Lecce, Italy
Ospedale San Raffaele
Milan, 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
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
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 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 Universitario de Canarias
San Cristóbal de La Laguna, Spain
Hospital Clinico Universitario
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Universitari "La Fe"
Valencia, Spain
Sunderby Hospital
Luleå, Sweden
Skåne Universitetssjukhus Univ Hospital Lund
Lund, Sweden
Inselspital Bern
Bern, Switzerland
Kings College Hospital and Guys and St Thomas' Hospital
London, United Kingdom
Related Publications (1)
Kantarjian HM, Begna KH, Altman JK, Goldberg SL, Sekeres MA, Strickland SA, Arellano ML, Claxton DF, Baer MR, Gautier M, Berman E, Seiter K, Solomon SR, Schiller GJ, Luger SM, Butrym A, Gaidano G, Thomas XG, Montesinos P, Rizzieri DA, Quick DP, Venugopal P, Gaur R, Maness LJ, Kadia TM, Ravandi F, Buyse ME, Chiao JH. Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS). Cancer. 2021 Dec 1;127(23):4421-4431. doi: 10.1002/cncr.33828. Epub 2021 Aug 23.
PMID: 34424530RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Point to note: The Lead-in AML patients in the sapacitabine-decitabine alternate dosing arm (n=21) were not considered for efficacy assessment.
Results Point of Contact
- Title
- Mark H. Kirschbaum MD
- Organization
- Cyclacel Ltd
Study Officials
- STUDY CHAIR
Hagop M Kantarjian, M.D.
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2011
First Posted
February 25, 2011
Study Start
October 1, 2011
Primary Completion
December 15, 2016
Study Completion
July 31, 2017
Last Updated
June 22, 2022
Results First Posted
June 22, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share