Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)
Phase II Randomized Study of Lower Doses of Decitabine (DAC; 20 mg/m2 IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 3 Days Every Month) Versus Azacitidine (AZA; 75 mg/m2 SC/IV Daily for 5 Days Every Month) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Dependent Versus Best Supportive Care (BSC) in MDS Patients With Low and Intermediate-1 Risk Disease Transfusion-Independent
2 other identifiers
interventional
185
1 country
6
Brief Summary
The goal of this clinical research study is to compare how 2 different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS. The safety of each study drug given on these schedules will also be studied. This is an investigational study. Decitabine and azacitidine are both FDA approved and commercially available for use in patients with MDS. Giving these drugs on a different schedule than is standard is considered investigational. The study doctor can tell you how the study drugs are designed to work.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started Oct 2014
Longer than P75 for phase_2 leukemia
6 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
October 13, 2014
CompletedStudy Start
First participant enrolled
October 13, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2024
CompletedResults Posted
Study results publicly available
August 7, 2025
CompletedAugust 7, 2025
July 1, 2025
9.8 years
October 13, 2014
July 2, 2025
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event Free Survival (EFS)
Event free survival (EFS) defined as the time from beginning of treatment till an event occurs or last follow-up. For transfusion independent patients, the events includes lack of response, requirement of blood transfusion, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death. For transfusion dependent patients, the events includes lack of response, progression to advanced stages of disease, transformation into AML, discontinuation of therapy due to side effects, and death.
Up to 8 years, 9 months and 12 days
Secondary Outcomes (1)
Number of Participants With Overall Improvement
Up to 8 years, 9 months and 12 days
Study Arms (4)
Azacitidine (AZA) - Days 1 - 3
EXPERIMENTALAzacitidine (AZA) Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Azacitidine (AZA) - Days 1 - 5
EXPERIMENTALAzacitidine (AZA) 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Decitabine (DAC)
EXPERIMENTALDecitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Best Supportive Care (BSC)
OTHERParticipants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
Interventions
Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
Eligibility Criteria
You may qualify if:
- Sign an IRB-approved informed consent document.
- Age \>/= 18 years.
- IPSS low- or intermediate-1-risk MDS, including CMML-1
- ECOG performance status of \</= 3 at study entry.
- Organ function defined as: Serum creatinine \</= 2 mg/dL; Total bilirubin \</= 2 x ULN; ALT (SGPT) \</= 2 x ULN; AST (SGOT) \</= 2 x ULN
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
You may not qualify if:
- Breast feeding females
- Prior therapy with decitabine or azacitidine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (6)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Guillermo Garcia-Mnaero
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo Garcia-Manero
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2014
First Posted
October 21, 2014
Study Start
October 13, 2014
Primary Completion
July 25, 2024
Study Completion
July 25, 2024
Last Updated
August 7, 2025
Results First Posted
August 7, 2025
Record last verified: 2025-07