|Canadian Cancer Trials Group MDC.1 (SWOG S1117) study - A Randomized Phase II Study of Azacitidine in Combination With Lenalidomide vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) - was centrally activated on November 22, 2012.
The objectives of this trial are to:
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- Test whether the response rate (complete remission, partial remission, or hematologic improvement) of patients with higher-risk MDS or CMML who receive either the combination of lenalidomide and azacitidine or the combination of vorinostat and azacitidine is improved compared to patients who receive single-agent azacitidine;
- Estimate relapse-free survival, overall survival and cytogenetic response rate of patients treated on each regimen;
- Estimate the frequency and severity of toxicities of the three regimens in this patient population;
- Investigate in a preliminary manner the frequency of subgroups from prestudy cytogenetic studies and correlate these subgroups with clinical outcomes in this patient population; and,
- Collect specimens for banking for use in future research studies.