drugset / Trial / NCT04281498

Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

NCT04281498

NaSingle-groupOpen-labelTreatment

Summary

The presence of IDH mutation is associated with worse survival in patients with myelofibrosis. Moreover IDH mutations are among the most frequently encountered events in MPNs that have progressed to acute myeloid leukemia. Ruxolitinib, a JAK1/2 inhibitor, and enasidenib an IDH2 inhibitor are effective and tolerable treatments for patients with myelofibrosis (MF) and acute myeloid leukemia (AML), respectively. The study team hypothesize that the combination of these agents in patients with MPN with an IDH2 mutation will improve the overall clinical response to therapy.

Timeline

Start
2021-01-14
Primary completion
2023-05-30
Completion
2023-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Enasidenib Small molecule 50 mg Oral
Subject Enasidenib Small molecule 100 mg Oral
Subject Ruxolitinib Small molecule Oral

Indications