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A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (SEAMLESS)

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sapacitabine
Decitabine
Sponsored by
Cyclacel Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • University of Alabama Comprehensive Cancer Center
  • Scripps Cancer Center
  • UCLA Ronald Reagan Medical Center
  • Norwalk Hospital
  • Shands Cancer Hospital at University of Florida
  • Cleveland Clinic Florida
  • Winship Cancer Institute, Emory University
  • Blood and Marrow Transplant Group of Georgia
  • Northwestern Memorial Hospital
  • Rush University Medical Center
  • The University of Chicago Medical Center
  • St. Francis Medical Group Oncology and Hematology Specialists
  • University of Iowa Hospitals and Clinics
  • University of Maryland Greenbaum Cancer Center
  • Beth Israel Deaconess Medical Center
  • Henry Ford Health System
  • Mayo Clinic
  • Saint Luke's Cancer Institute
  • St. Louis University Cancer Center
  • University of Nebraska Medical Center
  • Dartmouth - Hitchcock Medical Center
  • John Theurer Cancer Center at the Hackensack University Medical Center
  • Westchester Hematology Oncology Group, PC
  • Beth Israel Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Stony Brook University Medical Center
  • Duke University Medical Center
  • Gabrail Cancer Center Research
  • University of Cincinnati
  • Cleveland Clinic Foundation
  • Penn State Milton S. Hershey Medical Center
  • Abramson Cancer Center of the University of Pennsylvania
  • Saint Francis Hospital
  • Vanderbilt University Medical Center
  • Baylor University Medical Center
  • MD Anderson Cancer Center
  • Joe Arrington Cancer Research and Treatment Center
  • Huntsman Cancer Institute at the University of Utah
  • The Medical College of Wisconsin
  • Medizinische Universitaetsklinik
  • Elisabethinen Krankenhaus
  • Krankenhaus der Barmherzigen Schwestern
  • Univ. Klinik fur Innere Medizin III LKH
  • Klinikum Wels-Grieskirchen GmbH
  • AKH Wien
  • Hanusch Krankenhaus
  • Ziekenhuis Netwerk Antwerpen Stuivenberg
  • AZ Sint-Jan Brugge-Oostende
  • Universite Catholique de Louvain
  • Centre Hospitalier De Jolimont-Lobbes
  • Cliniques Universitaires UCL de Mont-Godinne
  • CHU d'Amiens Hopital Sud
  • Centre Hospitalier de la Cote Basque
  • CHU de Lyon - Hopital Edouard Herriot
  • Institut Paoli Calmettes
  • CHRU De Montpellier Hopital St. Eloi
  • Centre Hospitalier De Mulhouse
  • Hopital St Louis Universite Paris 7
  • Centre Hospitalier de Perigueux
  • Centre Hospitalier d'Annecy
  • Centre Hospitalier de Saint-Brieuc Yves Ie Foll
  • CHU de Strasbourg - Hopital Civil
  • Strasbourg Oncologie Liberale
  • CHU de Tours Hopital Bretonneau
  • Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin
  • Universitaetsklinikum Carl-Gustav-Carus Dresden
  • St. Johannes Hospital
  • Klinikum Frankfurt Hoechst
  • Asklepios Klinik Altona
  • Medizinische Hochschule Hannover
  • SLK Kliniken Heilbronn
  • Klinikum St. Georg
  • Johannes Wesling Klinikum
  • TU Muenchen
  • Universitaetsklinikum Muenster
  • University of Debrecen
  • Petz Aladar Megyei Oktato Korhaz
  • Kaposi Mor Oktato Korhaz
  • AOU Ospedali Riuniti Umberto I
  • AO Ospedali Riuniti di Bergamo
  • Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli
  • AO Spedali Civili di Brescia
  • Universita Cattolica del Sacro Cuore
  • AOU Careggi
  • AOU San Martino IST
  • PO Vito Fazzi
  • Ospedale San Raffaele
  • AORN Antonio Cardarelli
  • Uni. Napoli Ospedale Federico lI
  • AOU Maggiore della Carità di Novara
  • AOOR Villa Sofia Cervello di Palermo
  • Policlinico San Matteo Di Pavia
  • AOU San Luigi Gonzaga
  • Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku
  • Wojewodzki Szpital Specjalistyczny
  • Wojewódzki Szpital Specjalistyczny w Legnicy
  • University of Lodz N. Copernicus Memorial Hospital
  • IHT Instytut Hematologii I Transfuzjologii w Warszawie
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu
  • Hospital Universitari Germans Trias i Pujol ICO Badalona
  • Hospital Clinic de Barcelona
  • Hospital De La Santa Creu Sant Pau
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario de Canarias
  • Hospital Universitario Ramon y Cajal
  • MD Anderson Cancer Center
  • Hospital Son Llatzer
  • Hospital Universitari Son Espases
  • Clínica Universidad de Navarra
  • Complejo Hospitalario de Navarra
  • Hospital Clinico Universitario de Salamanca
  • Hospital Clinico Universitario
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitari "La Fe"
  • Sunderby Hospital
  • Skåne Universitetssjukhus Univ Hospital Lund
  • Inselspital Bern
  • Kings College Hospital and Guys and St Thomas' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sapacitabine-decitabine alternating

Decitabine

Arm Description

Arm A sapacitabine administered in alternating cycles with decitabine

Arm C Decitabine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complete Remission (CR)
Normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to <=5 % blasts; independent of transfusions*; and no extramedullary leukemia. * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Complete Remission With Incomplete Platelet Count Recovery (CRp)
Normalization of bone marrow to <=5% blasts; peripheral neutrophils >=1000 /microliter, platelet <=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions*; and no extramedullary leukemia. *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Partial Remission (PR)
Normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, >=50% decrease in bone marrow blasts over pre-treatment but still >5%; independent of transfusions* *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Hematological Improvement
HI with duration (HI) Erythroid response (HI-E) for patients with pre-treatment hemoglobin < 11 g/dL; Major response: >2 g/dL increase in hemoglobin; for RBC, transfusion independence* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements Platelet response (HI-P) for pre-treatment platelet count <100,000/mm3; Major response: an absolute increase of platelet count by >=30,000/mm3; stabilization of platelet counts and platelet transfusion independence* Minor response: >=50% increase in platelet count with a net increase > 10,000/mm3 but <30,000/mm3 Neutrophil response (HI-N) for absolute neutrophil count (ANC) < 1,500/mm3 before therapy; Major response: >=100% increase, or an absolute increase of >500/mm3, whichever is greater Minor response: >=100% increase, but absolute increase < 500/mm3 independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Stable Disease (SD)
Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for > 16 weeks.
Blood Products Transfused
Number of units of packed red blood cells (PRBC) and/or platelet transfusions administered per 8-week period prior to the first dose of study drug and through the date of treatment discontinuation.
Hospitalized Days
In-patient days in hospital.
1-year Survival
One-year survival is the percentage of patients who are alive at 1-year measured from the date of randomization.
Duration of Complete Remission (dCR)
Durations of normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to <=5 % blasts; independent of transfusions*; and no extramedullary leukemia. * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)
Duration of normalization of bone marrow to <=5% blasts; peripheral neutrophils >=1000 /microliter, platelet <=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions*; and no extramedullary leukemia. *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Duration of Partial Remission (dPR)
Duration of normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, >=50% decrease in bone marrow blasts over pre-treatment but still >5%; independent of transfusions* *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Duration of Hematological Improvement (dHI)
Duration of HI Erythroid response (HI-E) for patients with pre-treatment hemoglobin < 11 g/dL; Major response: >2 g/dL increase in hemoglobin; for RBC, transfusion independence* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements Platelet response (HI-P) for pre-treatment platelet count <100,000/mm3; Major response: an absolute increase of platelet count by >=30,000/mm3; stabilization of platelet counts and platelet transfusion independence* Minor response: >=50% increase in platelet count with a net increase > 10,000/mm3 but <30,000/mm3 Neutrophil response (HI-N) for absolute neutrophil count (ANC) < 1,500/mm3 before therapy; Major response: >=100% increase, or an absolute increase of >500/mm3, whichever is greater Minor response: >=100% increase, but absolute increase < 500/mm3 independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Duration of Stable Disease (dSD)
Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for > 16 weeks.

Full Information

First Posted
February 21, 2011
Last Updated
May 26, 2022
Sponsor
Cyclacel Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01303796
Brief Title
A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Acronym
SEAMLESS
Official Title
A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2011 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cyclacel Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a multicenter, randomized, Phase 3 study ("SEAMLESS") comparing 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, 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 Arm A versus Arm C.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
482 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sapacitabine-decitabine alternating
Arm Type
Experimental
Arm Description
Arm A sapacitabine administered in alternating cycles with decitabine
Arm Title
Decitabine
Arm Type
Active Comparator
Arm Description
Arm C Decitabine
Intervention Type
Drug
Intervention Name(s)
Sapacitabine
Other Intervention Name(s)
CYC682
Intervention Description
Oral sapacitabine capsules
Intervention Type
Drug
Intervention Name(s)
Decitabine
Other Intervention Name(s)
Decitabine intravenous
Intervention Description
Decitabine intravenous
Primary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
up to 43 months
Secondary Outcome Measure Information:
Title
Complete Remission (CR)
Description
Normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to <=5 % blasts; independent of transfusions*; and no extramedullary leukemia. * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Time Frame
up to 43 months
Title
Complete Remission With Incomplete Platelet Count Recovery (CRp)
Description
Normalization of bone marrow to <=5% blasts; peripheral neutrophils >=1000 /microliter, platelet <=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions*; and no extramedullary leukemia. *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Time Frame
up to 43 months
Title
Partial Remission (PR)
Description
Normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, >=50% decrease in bone marrow blasts over pre-treatment but still >5%; independent of transfusions* *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Time Frame
up to 43 months
Title
Hematological Improvement
Description
HI with duration (HI) Erythroid response (HI-E) for patients with pre-treatment hemoglobin < 11 g/dL; Major response: >2 g/dL increase in hemoglobin; for RBC, transfusion independence* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements Platelet response (HI-P) for pre-treatment platelet count <100,000/mm3; Major response: an absolute increase of platelet count by >=30,000/mm3; stabilization of platelet counts and platelet transfusion independence* Minor response: >=50% increase in platelet count with a net increase > 10,000/mm3 but <30,000/mm3 Neutrophil response (HI-N) for absolute neutrophil count (ANC) < 1,500/mm3 before therapy; Major response: >=100% increase, or an absolute increase of >500/mm3, whichever is greater Minor response: >=100% increase, but absolute increase < 500/mm3 independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Time Frame
up to 43 months
Title
Stable Disease (SD)
Description
Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for > 16 weeks.
Time Frame
up to 43 months
Title
Blood Products Transfused
Description
Number of units of packed red blood cells (PRBC) and/or platelet transfusions administered per 8-week period prior to the first dose of study drug and through the date of treatment discontinuation.
Time Frame
up to 43 months
Title
Hospitalized Days
Description
In-patient days in hospital.
Time Frame
up to 12 months
Title
1-year Survival
Description
One-year survival is the percentage of patients who are alive at 1-year measured from the date of randomization.
Time Frame
Percentage of patients alive at 1 year after randomization (participants were assessed up to 43 months for overall survival curve estimation but this measure presents the 1 year survival rate percentage).
Title
Duration of Complete Remission (dCR)
Description
Durations of normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, and bone marrow to <=5 % blasts; independent of transfusions*; and no extramedullary leukemia. * independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Time Frame
up to 43 months
Title
Duration of Complete Remission With Incomplete Platelet Count Recovery (dCRp)
Description
Duration of normalization of bone marrow to <=5% blasts; peripheral neutrophils >=1000 /microliter, platelet <=100,000 /microliter within 2 weeks of bone marrow biopsy/aspirate; independent of transfusions*; and no extramedullary leukemia. *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Time Frame
up to 43 months
Title
Duration of Partial Remission (dPR)
Description
Duration of normalization of peripheral neutrophils to >=1000 /microliter, platelet to >=100,000/microliter within 2 weeks of bone marrow biopsy/aspirate, >=50% decrease in bone marrow blasts over pre-treatment but still >5%; independent of transfusions* *independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Time Frame
up to 43 months
Title
Duration of Hematological Improvement (dHI)
Description
Duration of HI Erythroid response (HI-E) for patients with pre-treatment hemoglobin < 11 g/dL; Major response: >2 g/dL increase in hemoglobin; for RBC, transfusion independence* Minor response: 1 to 2 g/dL increase in hemoglobin; for RBC, a 50% decrease in transfusion requirements Platelet response (HI-P) for pre-treatment platelet count <100,000/mm3; Major response: an absolute increase of platelet count by >=30,000/mm3; stabilization of platelet counts and platelet transfusion independence* Minor response: >=50% increase in platelet count with a net increase > 10,000/mm3 but <30,000/mm3 Neutrophil response (HI-N) for absolute neutrophil count (ANC) < 1,500/mm3 before therapy; Major response: >=100% increase, or an absolute increase of >500/mm3, whichever is greater Minor response: >=100% increase, but absolute increase < 500/mm3 independent of transfusions refer to no platelet transfusion for 1 week prior to achieving the response
Time Frame
up to 43 months
Title
Duration of Stable Disease (dSD)
Description
Failure to achieve at least hematologic improvement (HI), but no evidence of clinically significant progression for > 16 weeks.
Time Frame
up to 43 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagop M Kantarjian, M.D.
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Scripps Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCLA Ronald Reagan Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Facility Name
Shands Cancer Hospital at University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Blood and Marrow Transplant Group of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
St. Francis Medical Group Oncology and Hematology Specialists
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Maryland Greenbaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Luke's Cancer Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Louis University Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Dartmouth - Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
John Theurer Cancer Center at the Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Westchester Hematology Oncology Group, PC
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3387
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Huntsman Cancer Institute at the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medizinische Universitaetsklinik
City
Innsbruck
Country
Austria
Facility Name
Elisabethinen Krankenhaus
City
Linz
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Schwestern
City
Linz
Country
Austria
Facility Name
Univ. Klinik fur Innere Medizin III LKH
City
Salzburg
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
Country
Austria
Facility Name
AKH Wien
City
Wien
Country
Austria
Facility Name
Hanusch Krankenhaus
City
Wien
Country
Austria
Facility Name
Ziekenhuis Netwerk Antwerpen Stuivenberg
City
Antwerpen
Country
Belgium
Facility Name
AZ Sint-Jan Brugge-Oostende
City
Brugge
Country
Belgium
Facility Name
Universite Catholique de Louvain
City
Brussels
Country
Belgium
Facility Name
Centre Hospitalier De Jolimont-Lobbes
City
La Louviere
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Godinne
City
Yvoir
Country
Belgium
Facility Name
CHU d'Amiens Hopital Sud
City
Amiens
Country
France
Facility Name
Centre Hospitalier de la Cote Basque
City
Bayonne
Country
France
Facility Name
CHU de Lyon - Hopital Edouard Herriot
City
Lyon
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
CHRU De Montpellier Hopital St. Eloi
City
Montpellier
Country
France
Facility Name
Centre Hospitalier De Mulhouse
City
Mulhouse
Country
France
Facility Name
Hopital St Louis Universite Paris 7
City
Paris
Country
France
Facility Name
Centre Hospitalier de Perigueux
City
Perigueux
Country
France
Facility Name
Centre Hospitalier d'Annecy
City
Pringy
Country
France
Facility Name
Centre Hospitalier de Saint-Brieuc Yves Ie Foll
City
St Brieuc
Country
France
Facility Name
CHU de Strasbourg - Hopital Civil
City
Strasbourg
Country
France
Facility Name
Strasbourg Oncologie Liberale
City
Strasbourg
Country
France
Facility Name
CHU de Tours Hopital Bretonneau
City
Tours
Country
France
Facility Name
Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin
City
Berlin
Country
Germany
Facility Name
Universitaetsklinikum Carl-Gustav-Carus Dresden
City
Dresden
Country
Germany
Facility Name
St. Johannes Hospital
City
Duisburg
Country
Germany
Facility Name
Klinikum Frankfurt Hoechst
City
Frankfurt
Country
Germany
Facility Name
Asklepios Klinik Altona
City
Hamburg
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
SLK Kliniken Heilbronn
City
Heilbronn
Country
Germany
Facility Name
Klinikum St. Georg
City
Leipzig
Country
Germany
Facility Name
Johannes Wesling Klinikum
City
Minden
Country
Germany
Facility Name
TU Muenchen
City
Muenchen
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
Country
Germany
Facility Name
University of Debrecen
City
Debrecen
Country
Hungary
Facility Name
Petz Aladar Megyei Oktato Korhaz
City
Győr
Country
Hungary
Facility Name
Kaposi Mor Oktato Korhaz
City
Kaposvár
Country
Hungary
Facility Name
AOU Ospedali Riuniti Umberto I
City
Ancona
Country
Italy
Facility Name
AO Ospedali Riuniti di Bergamo
City
Bergamo
Country
Italy
Facility Name
Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli
City
Bologna
Country
Italy
Facility Name
AO Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Universita Cattolica del Sacro Cuore
City
Campobasso
Country
Italy
Facility Name
AOU Careggi
City
Firenze
Country
Italy
Facility Name
AOU San Martino IST
City
Genova
Country
Italy
Facility Name
PO Vito Fazzi
City
Lecce
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
AORN Antonio Cardarelli
City
Napoli
Country
Italy
Facility Name
Uni. Napoli Ospedale Federico lI
City
Napoli
Country
Italy
Facility Name
AOU Maggiore della Carità di Novara
City
Novara
Country
Italy
Facility Name
AOOR Villa Sofia Cervello di Palermo
City
Palermo
Country
Italy
Facility Name
Policlinico San Matteo Di Pavia
City
Pavia
Country
Italy
Facility Name
AOU San Luigi Gonzaga
City
Torino
Country
Italy
Facility Name
Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku
City
Gdansk
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Legnica
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny w Legnicy
City
Legnica
Country
Poland
Facility Name
University of Lodz N. Copernicus Memorial Hospital
City
Lodz
Country
Poland
Facility Name
IHT Instytut Hematologii I Transfuzjologii w Warszawie
City
Warsaw
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu
City
Wroclaw
Country
Poland
Facility Name
Hospital Universitari Germans Trias i Pujol ICO Badalona
City
Badalona
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital De La Santa Creu Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
La Laguna
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Universitari Son Espases
City
Palma de Mallorca
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Clinico Universitario
City
Santiago de Compostela
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Universitari "La Fe"
City
Valencia
Country
Spain
Facility Name
Sunderby Hospital
City
Luleå
Country
Sweden
Facility Name
Skåne Universitetssjukhus Univ Hospital Lund
City
Lund
Country
Sweden
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
Kings College Hospital and Guys and St Thomas' Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34424530
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/34424530/
Description
Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS)

Learn more about this trial

A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

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