Phase Ib/II Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis
John Mascarenhas
Summary
This is a Phase Ib/II 2 study investigating the safety and efficacy of revumenib in two cohorts of participants with myelofibrosis. COHORT-1 will investigate the safety of revumenib as monotherapy in participants with myelofibrosis previously treated with a JAK inhibitor. Following confirmation of safety in COHORT-1, the study will proceed with enrollment in COHORT-2, which will evaluate the efficacy and safety of revumenib in combination with a JAK inhibitor.
Description
This is a Phase Ib/II 2 study investigating the safety and efficacy of revumenib in two cohorts of participants with myelofibrosis. COHORT-1 will investigate the safety of revumenib as monotherapy in participants with myelofibrosis previously treated with a JAK inhibitor. Following confirmation of safety in COHORT-1, the study will proceed with enrollment in COHORT-2, which will evaluate the efficacy and safety of revumenib in combination with a JAK inhibitor. COHORT-2 will enroll participants on stable dose of a JAK inhibitor (ruxolitinib, fedratinib, or momelotinib) for at least 12 weeks at…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Adults ≥ 18 years of age at time of signing the informed consent * Participants must voluntarily sign informed consent form (ICF) and be willing and able to adhere to the study visit schedule and all protocol requirements. * Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Participants must have a pathologically confirmed diagnosis of PMF, post-ET-MF or post-PV-MF as per the WHO diagnostic criteria, with intermediate-1 or higher risk dis…
Interventions
- DrugRevumenib
Dose Level 1: Revumenib 160mg twice daily or 110mg twice daily Dose Level 2: Revumenib 270mg twice daily or 160mg twice daily
- DrugRuxolitinib
Part of routine care. Participants to continue on dosage as prescribed by provider, 5 to 20 mg BID
- DrugFEDRATINIB
Part of routine care. Participants to continue on dosage as prescribed by provider, 100 mg to 400 mg daily.
- DrugMomelotinib
Part of routine care. Participants to continue on dosage as prescribed by provider, 100 mg to 200 mg daily.
Location
- Icahn School of Medicine at the Mount Sinai HospitalNew York, New York