Randomized Allogeneic Azacitidine Study
The goal of this clinical research study is to learn if Vidaza (azacitidine) will help to control the disease in patients with AML, CMML, or MDS after an allogeneic (donor) stem cell transplant. The safety of this drug will also be studied.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse|
- Relapse-free survival (RFS) Time [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
Goal is to test hypothesis that AZA provides at least a 50% improvement in m = median RFS, from 6 to 9 months. Complete response defined as bone marrow with < 6% blasts. Molecular studies of minimal residual disease not be required to define response.
Secondary graft failure defined as a sustained decline of ANC below 0.5 x 109/L for 3 consecutive days after initial documented engraftment with no evidence of disease progression.
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Azacitidine 32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.
32 mg/m^2 given through a needle under the skin for five consecutive days of each 28 day cycle and the maximum treatment will be 12 cycles.
No Intervention: No Azacitidine
Standard treatment post allogeneic transplant is supportive care only.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00887068
|Contact: Richard E. Champlin, MD, BS||713-792-8750|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Richard E. Champlin, MD, BS||M.D. Anderson Cancer Center|