Revumenib for Myelofibrosis

(MPN-RC 129 Trial)

GS
SF
Overseen ByShakira Forde
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: John Mascarenhas
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AM

Anthony M Hunter, MD

Principal Investigator

Emory University

JM

John Mascarenhas, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for people with myelofibrosis, a type of bone marrow cancer. Participants must have already been treated with a JAK inhibitor before joining. Other major health issues or conditions may prevent participation.

Inclusion Criteria

I am 18 years old or older.
Participants must voluntarily sign informed consent form (ICF) and be willing and able to adhere to the study visit schedule and all protocol requirements
I am able to care for myself and do light activities.
See 10 more

Exclusion Criteria

Immediate family member involved as investigational site or sponsor staff directly involved with trial unless IRB approval granted
I can take hydroxyurea up to the day before starting the study treatment.
I have had my spleen removed or treated within the last 6 months.
See 19 more

What Are the Treatments Tested in This Trial?

Interventions

  • Fedratinib
  • Momelotinib
  • Revumenib
  • Ruxolitinib

Trial Overview

The study tests revumenib alone first to check safety, then combines it with another drug called a JAK inhibitor (like ruxolitinib, fedratinib, or momelotinib) to see how well the combination works and how safe it is.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: COHORT-2 (revumenib added to JAK inhibitor therapy)Experimental Treatment4 Interventions
Group II: COHORT-1 (revumenib monotherapy)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

John Mascarenhas

Lead Sponsor

Trials
10
Recruited
220+

Syndax Pharmaceuticals

Industry Sponsor

Trials
49
Recruited
2,700+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+