Revumenib in Patients With Myelofibrosis
Starting soon · Phase 1/Phase 2
Conditions studied: Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
In brief
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 facts
- Study ID
- NCT07734077
- Run by
- John Mascarenhas
- People needed
- 32
- Starts
- 2026-12-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 disease by DIPSS (14.1).
- Criteria for COHORT-1 (Monotherapy): Treated with at least one prior line of JAK inhibitor therapy to which they were refractory/resistant, lost response, or intolerant, or is not a candidate for approved JAK inhibitor therapy per investigator judgement, and with one or more of the following features of active disease:
- Spleen palpable ≥ 5 cm below the left costal margin or > 450cm3 by MRI/CT
- MPN-SAF TSS ≥ 10
- Transfusion dependence (requiring at least 6 units of PRBCs in the 12 weeks prior to study enrollment, for a hemoglobin < 8.5g/dL in the absence of bleeding or treatment-induced anemia)
- Criteria for COHORT-2 (Combination therapy): Currently receiving treatment with an approved JAK inhibitor (including ruxolitinib, fedratinib, or momelotinib) with stable dose for at least 12 weeks prior to study enrollment, and with one or more of the following features of active disease:
- Spleen palpable ≥ 5 cm below the left costal margin or > 450cm3 by MRI/CT
- MPN-SAF TSS ≥ 10
- Transfusion dependence (requiring at least 6 units of PRBCs in the 12 weeks prior to study enrollment, for a hemoglobin < 8.5g/dL in the absence of bleeding or treatment-induced anemia)
- Adequate organ function as demonstrated by the following within 28 days prior to Cycle 1 Day 1:
- ALT (SGPT) and/or AST (SGOT) < 3 × the upper limit of normal (ULN), or < 5 × ULN if, upon judgment of the treating physician, it is believed to be due to MF-related extramedullary hematopoiesis (EMH);
- Total bilirubin < 3 × ULN for age (< 4 x ULN for age if attributed to MF related EMH or Gilbert's syndrome)
- Creatinine clearance ≥ 30 mL/min by Cockcroft Gault formula;
- Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × upper limit of normal (ULN)
- Adequate cardiac function defined as ejection fraction of ≥50% by echocardiogram or multigated acquisition (MUGA) scan
- Bone marrow and/or peripheral blood blast count < 10%;
- Absolute neutrophil count (ANC) ≥ 1000 mm3; and
- Platelet count ≥ 75 x 109/L at time of enrollment
- QTcF ≤ 450msec at screening
- Recovery to ≤ Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia
- Life expectancy of at least six months
Where it is running
- Icahn School of Medicine at the Mount Sinai Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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