Decitabine Versus Supportive Care in Adults With Advanced-stage MDS
A Randomized, Open-label, Phase III Trial of Decitabine (5-aza-2'Deoxycytidine) Versus Supportive Care in Adults With Advanced-stage Myelodysplastic Syndrome
1 other identifier
interventional
160
1 country
24
Brief Summary
To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2001
24 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
Study Start
First participant enrolled
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 8, 2002
CompletedFirst Posted
Study publicly available on registry
August 12, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2003
CompletedAugust 2, 2024
August 1, 2024
1.6 years
August 8, 2002
August 1, 2024
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- MDS (de novo or secondary) fitting any of the recognized French-American-British, FAB, classifications or chronic myelomonocytic leukemia (CMML) with WBC \< 12,000/mm3, AND International Prognostic Scoring System (IPSS) \>/= 0.5 as determined by CBC, bone marrow assessment and bone marrow cytogenetics within 30 days of randomization
- years or older
- Female patients of child-bearing potential must have a negative serum hCG within 24 hours prior to randomization, must practice a medically approved method of birth control for the past 30 days, and agree to continue this practice for the trial duration and must not be breast-feeding
- ECOG or WHO performance status of 0-2
- Written informed consent
- Normal renal and hepatic function (creatinine \</= 2 mg/dL, bilirubin \</= 1.5 mg/dL, SGPT \</= 2 times the upper limit of normal range)
You may not qualify if:
- Acute Myeloid Leukemia (AML) (\>/=30% bone marrow blasts) or other progressive malignant disease
- Patients must have recovered from the toxic effects of prior therapy and must be off all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a minimum of six weeks for prior nitrosoureas and bone marrow transplantation)
- Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or other agents used to treat MDS within 7 days of study initiation.
- Administration of any investigational agent within the 30 days preceding study initiation.
- Uncontrolled cardiac disease or congestive heart failure
- Uncontrolled restrictive or obstructive pulmonary disease
- Active viral or bacterial infection
- Superimposed autoimmune hemolytic anemia or thrombocytopenia
- Known positive serology for HIV
- Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
City of Hope National Medical Center
Duarte, California, United States
Scripps Clinic
Escondido, California, United States
Loma Linda Univ. Cancer Center
Loma Linda, California, United States
Univ. California San Francisco Medical School
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
James A. Haley Veteran's Hospital
Tampa, Florida, United States
Rush Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
VA Medical Center
Minneapolis, Minnesota, United States
Washington Univ. School of Medicine
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Memphis Cancer Center
Memphis, Tennessee, United States
SW Regional Cancer Center (dba Central Texas Oncology Associates)
Austin, Texas, United States
Texas Oncology
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Related Publications (2)
Jabbour E, Kantarjian H, O'Brien S, Kadia T, Malik A, Welch MA, Teng A, Cortes J, Ravandi F, Garcia-Manero G. Retrospective analysis of prognostic factors associated with response and overall survival by baseline marrow blast percentage in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):592-6. doi: 10.1016/j.clml.2013.05.004. Epub 2013 Jun 20.
PMID: 23790798DERIVEDJabbour E, Garcia-Manero G, Ravandi F, Faderl S, O'Brien S, Fullmer A, Cortes JE, Wierda W, Kantarjian H. Prognostic factors associated with disease progression and overall survival in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):131-8. doi: 10.1016/j.clml.2012.11.001. Epub 2012 Dec 21.
PMID: 23260600DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 8, 2002
First Posted
August 12, 2002
Study Start
April 1, 2001
Primary Completion
November 1, 2002
Study Completion
April 1, 2003
Last Updated
August 2, 2024
Record last verified: 2024-08