drugset / Trial / NCT05282459

Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation

NCT05282459

NaSequentialOpen-labelTreatment

Summary

This is a phase 1b/2, open-label, single arm study to evaluate if enasidenib is safe and effective in improving anemia and decreasing transfusion needs in subjects diagnosed with lower risk myelodysplastic syndrome (MDS) or nonproliferative chronic myelomonocytic leukemia (CMML) without a mutation in isocitrate dehydrogenase type 2 (IDH2 wildtype). Other objectives include assessment of improvements in platelet production and characterization of the mechanism of action of enasidenib in enhancing endogenous erythropoiesis.

Timeline

Start
2022-01-12
Primary completion
2024-12-03
Completion
2025-03-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Enasidenib Small molecule 100 mg Oral