Spots Global Cancer Trial Database for A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia

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Trial Identification

Brief Title: A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia

Official Title: A Phase II Study of the Efficacy, Safety and Determinants of Response to 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia (CMML)

Study ID: NCT01350947

Conditions

Chronic Myelomonocytic Leukemia

Interventions

5-Azacitidine

Study Description

Brief Summary: The primary objective of this study is: Response to treatment will be evaluated according to the revised International Working Group (IWG) categories natural history, hematologic improvement and cytogenetic response1;2. The primary objective is: To determine the rate of complete hematologic response and hematologic improvement (according to IWG 2006 criteria) in CMML patients treated with 5-azacitidine.

Detailed Description: In this study, eligible patients with a confirmed diagnosis of CMML will be treated with 5-azacitidine to determine the rates of complete hematologic response, hematologic improvement, complete and partial cytogenetic response, and overall and progression free survival. To develop biomarkers associated with response and gain insights into the mechanisms that determine response, gene expression profiling, genome-wide SNP array analysis, microRNA analysis, and DNA methylation analysis will be performed prior to therapy and at defined time points during the study. Phosphoproteomics profiling may be included in the analysis.