Ruxolitinib + Enasidenib for Myelofibrosis

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byMichal Bar-Natan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: John Mascarenhas

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Subjects must be ≥ 18 years at the time of signing the Informed Consent Form (ICF).

Understanding and voluntary signing an IRB-approved informed consent form.

Diagnosis of 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)

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Exclusion Criteria

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form, which places the subject at unacceptable risk if he/she were to participate in the study or which confounds the ability to interpret data from the study.

Lactating females.

Active uncontrolled infections.

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