CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
Ruxolitinib +1 moredrug
Likely dose
Enasidenib 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04281498
NCT04281498Phase 2Completed

A Phase II Open-label Study of Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

John Mascarenhas·interventional·Posted Feb 24, 2020·Updated Feb 4, 2025

In Brief

A Phase 2 clinical trial evaluating Ruxolitinib and Enasidenib for Accelerated/Blast-phase Myeloproliferative Neoplasm and 2 related conditions. Completed, enrolled 6 participants across 11 sites in 2 countries.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 24, 2020
Enrollment StartJan 14, 2021
Primary CompletionMay 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.4 years ago

Interventions

Ruxolitinibdrug

Patients who are on ruxolitinib will continue their current dose. Patients who are not on ruxolitinib will receive ruxolitinib dosing based on platelet count

Enasidenibdrug

50mg -100mg daily