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Revumenib in Patients With Myelofibrosis

NCT07734077 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-29

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Revumenib

Dose Level 1: Revumenib 160mg twice daily or 110mg twice daily Dose Level 2: Revumenib 270mg twice daily or 160mg twice daily

DRUG

Ruxolitinib

Part of routine care. Participants to continue on dosage as prescribed by provider, 5 to 20 mg BID

DRUG

FEDRATINIB

Part of routine care. Participants to continue on dosage as prescribed by provider, 100 mg to 400 mg daily.

DRUG

Momelotinib

Part of routine care. Participants to continue on dosage as prescribed by provider, 100 mg to 200 mg daily.

Sponsors & Collaborators

  • Syndax Pharmaceuticals

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • John Mascarenhas

    lead OTHER

Principal Investigators

  • John Mascarenhas, MD · Icahn School of Medicine at Mount Sinai

  • Anthony M Hunter, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2028-12-01
Completion
2028-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734077 on ClinicalTrials.gov