Decitabine Versus Azacitidine in Myelodysplastic Syndrome Patients With Low and Intermediate-1 Risk
The goal of this clinical research study is to compare how two different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule can help to control MDS. The safety of the drugs will also be studied.
Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.
Azacitidine is designed to block certain proteins in cancer cells whose job is to stop the function of the tumor-fighting proteins. By blocking the "bad" proteins, the tumor-fighting genes may be able to work better. This could cause the cancer cells to die.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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) in Myelodysplastic Syndrome (MDS) Patients With Low and Intermediate-1 Risk Disease|
- Overall Improvement Rate (OIR) [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]Overall improvement rate (OIR), defined as complete remission (CR), partial remission (PR), marrow CR (mCR), or hematologic improvement (HI), measured at the end of each cycle using each patient's best response with the 2 different agents. Response assessed using the modified International Working Group 2006 criteria. The best response within the first two cycles will be the OIR for each treatment arm that will be used in the adaptive randomization algorithm.
- Transfusion Independence [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Transfusion independence defined as being transfusion-free for ≥8 consecutive weeks between the first dose and study treatment discontinuation.
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Patients randomized to receive Decitabine 20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.
20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.
Patients randomized to receive Azacitidine 75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.
75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01720225
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Elias Jabbour, MD||M.D. Anderson Cancer Center|