A Phase II Study of the Efficacy, Safety and Determinants of Response to 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia (CMML)
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the rate of complete hematologic response and hematologic improvement (according to IWG 2006 criteria) in CMML patients treated with 5-azacitidine.
24 months
No
Michael Deininger, MD
Principal Investigator
University of Utah
United States: Institutional Review Board
HCI47081
NCT01350947
April 2011
December 2013
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Utah | Salt Lake City, Utah |
Oregon Health and Science University | Portland, Oregon 97201 |