Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network
About this trial
The purpose of this study is to compare momelotinib and ruxolitinib as treatments for myelofibrosis with low blood cell counts. Both drugs are approved by the FDA to treat myelofibrosis. The study asks which drug does a better job at shrinking the spleen.
Eligibility criteria
Qualifiers
Participants must have confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (PV) MF or post-essential thrombocythemia (ET) MF as assessed by the treating physician per 2022 WHO classification, and confirmed by a bone marrow biopsy within four years.
Participants must have a spleen measuring ≥ 450 cm3 by MRI within 14 days prior to Step 1 registration. For participants with a medical contraindication to MRI or if MRI is unavailable, a CT scan may be performed.
Participants must have DIPSS risk category of Intermediate-1, Intermediate-2 or High per Dynamic International Prognostic Scoring System (DIPSS) for MF.
Participants must have blasts <10% in peripheral blood within 28 days of Step 1 registration. If bone marrow biopsy performed within 28 days prior to Step 1 registration blasts must be <10% as well.
Disqualifiers
Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.
Participants must not be considered eligible for hematopoietic stem cell transplantation (HSCT) or have prior HSCT for MF.
Participants must not have received prior JAK or ACVR1 inhibitor treatment.
Participants must not have received investigational therapy within 14 days prior to Step 1 registration.
Trial design
Treatments tested in this trial
- Momelotinib
- Ruxolitinib
Treatment groups
268 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
SWOG Cancer Research Network
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov