Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00887068|
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Leukemia AML MDS||Drug: Azacitidine||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||187 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)|
|Actual Study Start Date :||April 21, 2009|
|Actual Primary Completion Date :||August 20, 2018|
|Actual Study Completion Date :||August 20, 2018|
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.
- Relapse-free survival (RFS) Time [ Time Frame: 3, 6, and 12 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887068
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Richard E. Champlin, MD, BS||M.D. Anderson Cancer Center|