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 2016 (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.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:
- If you are in Group 1, you will receive decitabine by vein over about 1 hour.
- If you are in Group 2, you will receive azacitidine either as an injection under your skin or through a vein. If by vein, the infusion will take about an hour.
At first, there will be an equal chance of being assigned to either group. However, as the study goes on and more information becomes available, the chance of being assigned to the group that has shown the most effectiveness will increase. However, once you are already enrolled and assigned to a group, you will not be eligible to change groups.
Study Drug Administration:
Each cycle is 28 days.
You will receive the study drug on Days 1-3 of every cycle and you will receive at least 2 cycles of study drug.
Every 7-14 days, blood (about 2 tablespoons) will be drawn for routine tests.
Every 2-4 cycles until any point that the disease appears to have responded to the study drug, then as often as the study doctor thinks is necessary, you will have a bone marrow biopsy and/or aspirate to check the status of the disease. To collect a bone marrow biopsy/aspirate, an area of the hip bone is numbed with anesthetic, and a small amount of bone and/or bone marrow is withdrawn through a large needle.
The frequency of the visits will depend on what the doctor thinks is in your best interest.
Length of Study:
You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
One (1) time every 3 months after your last dose of study drug, you will return to the clinic for a bone marrow aspiration to check the status of the disease.
This is an investigational study. Decitabine and Azacitidine are both FDA approved and commercially available for use in patients with MDS.
Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.
|Contact: Elias Jabbour, MD||713-792-7305|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Elias Jabbour, MD||UT MD Anderson Cancer Center|