Revumenib in Patients With Myelofibrosis

Part of paid clinical trials in New York, New York.

Sponsor
John Mascarenhas
Study ID
NCT07734077
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Myelofibrosis
  • Post-essential Thrombocythemia Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Revumenib — DRUG
    Dose Level 1: Revumenib 160mg twice daily or 110mg twice daily Dose Level 2: Revumenib 270mg twice daily or 160mg twice daily
  • Ruxolitinib — DRUG
    Part of routine care. Participants to continue on dosage as prescribed by provider, 5 to 20 mg BID
  • FEDRATINIB — DRUG
    Part of routine care. Participants to continue on dosage as prescribed by provider, 100 mg to 400 mg daily.
  • Momelotinib — DRUG
    Part of routine care. Participants to continue on dosage as prescribed by provider, 100 mg to 200 mg daily.

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Dec 1, 2026
Status verified
Jul 2026
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: COHORT-1 (revumenib monotherapy)
    Revumenib monotherapy utilizing a 3+3 dose-escalation design
  • Experimental: COHORT-2 (revumenib added to JAK inhibitor therapy)
    Dosage of revumenib from Cohort 1 plus JAK inhibitor therapy (ruxolitinib, fedratinib, or momelotinib)

Primary Outcome Measure

Dose limiting toxicity (DLT) [ Time Frame: 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at the Mount Sinai HospitalNew YorkNew York10029
Gillian Sanchez
[email protected]
Gabriela Bello
[email protected]
John Mascarenhas (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Icahn School of Medicine at the Mount Sinai Hospital· New York, NY

Related Studies