drugset / Trial / NCT05282459
Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation
Phase 1/2
Completed
17 enrolled
Tian Yi Zhang
Bristol-Myers Squibb · collabCelgene Corporation · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enasidenib | Small molecule | 100 mg | Oral |