NCT07104799 Momelotinib During and After HCT in Myelofibrosis
| NCT ID | NCT07104799 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Myelofibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2028-01 |
Trial Parameters
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Brief Summary
This is a single-center, open-label, phase I study to determine the safety and tolerability of momelotinib in patients with myelofibrosis during and after hematopoietic cell transplantation (HCT).
Eligibility Criteria
Inclusion Criteria: * Participants must have pathologically confirmed primary myelofibrosis (PMF) according to WHO criteria or secondary myelofibrosis as defined by the IWG-MRT criteria. * Intermediate-2/ high-risk disease as per Dynamic IPSS (DIPSS) Plus criteria OR * Intermediate-1 risk disease with at least one of the following unfavorable features known to impact the survival adversely * Red cell transfusion dependency * Unfavorable Karyotype * Platelet count ≤100 x 10\^9/L * Presence of a high risk molecular marker associated with worsened overall survival (ASXL1, EZH2, IDH1/2, SRSF2, U2AF1, p53) * Participants do not have to be receiving treatment with JAK inhibitors for MF at the time of enrollment. If participants are receiving JAK inhibitor therapy with agents other momelotinib, participants must agree to be switched to momelotinib to begin Cycle 1 Day 1 on Day -7 from HCT (at the initiation of conditioning). * Age \>18 years * Participants must be designated to undergo alloge