Momelotinib During and After HCT in Myelofibrosis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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
Qualifiers
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
Disqualifiers
Known intolerance or hypersensitivity to any JAK inhibitor, including ruxolitinib, fedratinib, pacritinib, momelotinib or any other JAK inhibitor, its metabolites or formulation excipients.
Has had any major surgery within 28 days prior to randomization
Has received treatment with an investigational agent within 4 weeks of the first dose of study intervention
Has received immunosuppressive agents within 28 days
Trial design
Treatments tested in this trial
- Momelotinib
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov