Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)
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|ClinicalTrials.gov Identifier: NCT00887068|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2009
Last Update Posted : April 17, 2017
|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|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
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|