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) versus Azacitidine (AZA 75 mg/m2 SC/IV daily for 5 days every month) in MDS Patients with Low and Intermediate-1 Risk Disease Transfusion-Dependent versus Best Supportive Care (BSC) in MDS Patients with Low and Intermediate-1 Risk Disease Transfusion-Independent
The goal of this clinical research study is to compare how 2 different drugs, decitabine and azacitidine, when given on a shorter than standard dosing schedule, may help to control MDS. The safety of each study drug given on these schedules will also be studied.
Disease Group: Leukemia
Treatment Agent: Azacitidine,Decitabine
Treatment Location: Both at MD Anderson & Other Sites
Sponsor: MDS Consortium
Primary: Compare the event-free survival rates of two different drugs: DAC versus AZA on an abbreviated schedule to a standard arm of AZA given over 5 days in patients with low-risk MDS transfusion-dependent and to BSC in patients with low-risk MDS transfusion-independent. Secondary: Compare the response rates for the transfusion independent and the transfusion dependent patients. For example the response rate of two different drugs DAC versus AZA on abbreviated schedule to a standard arm of AZA given over 5 days. Evaluate the durability of response, the overall and transformation-free survival rates, and the safety profile of 2 different drugs. The quality of life protocol (2014-0636) titled “Interventional Validation of an MDS-Specific Measure of Quality of Life: Assessing the Responsiveness of the QUALMS-1 to Different Hypomethylating Agent Regimens for Low and Intermediate Risk Disease” was written specifically as a companion study to protocol 2014-0112 and may be offered as an optional assessment to patients enrolled onto this protocol.
IRB Review and Approval Date: 10/13/2014
Recruitment Status: Open
Projected Accrual: 240
1) Sign an IRB-approved informed consent document.
2) Age >/= 18 years.
3) IPSS low- or intermediate-1-risk MDS, including CMML-1
4) ECOG performance status of </= 3 at study entry.
5) Organ function defined as: Serum creatinine </= 2 mg/dL; Total bilirubin </= 2 x ULN; ALT (SGPT) </= 2 x ULN; AST (SGOT) </= 2 x ULN
6) Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and will also need to use contraceptives. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
1) Breast feeding females
2) Prior therapy with decitabine or azacitidine
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