CompletedPhase 2

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

United States6 participantsStarted 2021-01-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Accelerated-phase (≥ 10% blasts in PB or BM) or blast-phase (≥ 20% blasts in PB or BM) myeloproliferative neoplasm (with history of prior myelofibrosis, polycythemia vera, or essential thrombocythemia)
✓. Previously treated patients with myelofibrosis with persistent disease or progressive disease (persistent or progressive splenomegaly, leukocytosis, anemia, or thrombocytopenia) with intermediate-1 or greater risk disease according to 2013 International Working Group (IWG) criteria, and 4-9% circulating blasts.

What they're measuring

Number of MPN Participants With Response

Timeframe: 6 Months

Trial details

NCT IDNCT04281498

SponsorJohn Mascarenhas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-30

Results submitted2024-11-21

View on ClinicalTrials.gov More Accelerated/Blast-phase Myeloproliferative Neoplasm trials