Status:
COMPLETED
Phase II Decitabine (DAC) Versus Azacitidine (AZA) in Myelodysplastic Syndrome (MDS)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Detailed Description
Study Groups and Study Drug Administration: Each cycle is approximately 28 days. If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Breast feeding females
- Prior therapy with decitabine or azacitidine
Key Trial Info
Start Date :
October 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2024
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT02269280
Start Date
October 13 2014
End Date
July 25 2024
Last Update
August 7 2025
Active Locations (6)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065