Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts

ConditionsMyelofibrosis Myelofibrosis (MF)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Momelotinib
Drug
200 mg daily x 96 weeks.
Ruxolitinib
Drug
Twice daily per treating investigator discretion not to exceed protocol specified guidelines.

Treatment groups

268 Participants

are divided into 2 treatment groups

Group A: MomelotinibActive comparator 1 intervention

Group B: RuxolitinibActive comparator 1 intervention

Trial outcomes

Primary outcomes

To estimate and compare the proportion of participants achieving a dual response [SVR35] and transfusion independence response from red blood cell transfusions.

To estimate and compare the proportion of patients achieving a dual response both spleen response \[SVR35\] and transfusion independence response \[TI-R\] from red blood cell transfusions at week 24 post-Step 1 randomization in JAK-inhibitor naïve participants with myelofibrosis treated with momelotinib versus ruxolitinib.

Time frame

24 weeks after randomization

Secondary outcomes

TI-R Rate

To estimate and compare the TI-R rate at week 24, post-Step 1 randomization in each treatment arm.

Time frame

24 weeks after Step 1 Randomization

SVR35 at week 24 post-randomization

To estimate and compare the rates of SVR35 at week 24 post-randomization in each treatment arm.

Time frame

24 weeks after Step 1 Randomization

To estimate overall survival (OS) in each treatment arm.

Time frame