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.
Hgb <10 g/dL
ANC <1.8 × 109/L
Platelets <100 × 109/L
IDH2 gene mutation (R140 or R172), performed locally, at a frequency ≥ 2%.
Indication of hematologic disease by bone marrow biopsy within 6 months of study entry.
Evidence of disease progression from time of bone marrow biopsy to enrollment based on investigator review of symptoms and complete blood counts
Active malignancy (defined as > 1 cm disease on most recent CT scan in the past 6 months).
Currently receiving therapy for solid tumor malignancy or received within the last 6 months.
Washington University School of Medicine
Lead sponsor
Bristol-Myers Squibb
Collaborator
Damon Runyon Cancer Research Foundation
Collaborator