Study researchers think that a drug called enasidenib may help people with clonal cytopenia of undetermined significance (CCUS) because the drug blocks the mutated IDH2 protein, which may improve blood cell counts. The purpose of this study is to find out whether enasidenib is a safe and effective treatment for CCUS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Provided by BMS.
Washington University School of Medicine
St Louis, Missouri, United States
RECRUITINGBest hematologic response
Hematologic response to enasidenib will be evaluated according to a modified version of the IWG 2006 Criteria for Hematologic Improvement for patients with MDS on clinical trials
Time frame: Up to 18 cycles (each cycle is 28 days) of treatment (up to approximately 17 months)
Toxicity as measured by the number of adverse events experienced by participant
Measured by CTCAE v 5.0
Time frame: From start of treatment through 30 days after the last day of treatment (up to approximately 18 months)
Change in mutant IDH2 variant allele fraction
The IDH2 variant allele fraction reflects the clonal dominance in the blood. Blood samples will be drawn at various time points throughout the study to determine the IDH2 variant allele fraction. The lower the IDH2 variant allele fraction the better the outcome.
Time frame: Baseline, day 1 of cycles 3/6/9/12/15 (each cycle is 28 days), and end of treatment (up to approximately 17 months)
Duration of hematologic improvement
Time frame: From start of treatment through completion of treatment (estimated to be 17 months)
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