A Phase 2 Open-label Study to Evaluate Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Primary or Secondary Myelofibrosis
GlaxoSmithKline
Summary
The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or Post-polycythemia vera (PV)/ essential thrombocythemia (ET) myelofibrosis (MF) who are either janus kinase (JAK) inhibitor (JAKi) naïve or experienced.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Is age ≥18 years. 2. Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET myelofibrosis in accordance with the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. 3. JAKi naïve or previously treated with either ruxolitinib or fedratinib for PMF or Post-PV/ET myelofibrosis for ≥90 days, or ≥28 days if JAKi therapy is complicated by RBC transfusion requirement of ≥4 units in 8 weeks, or Grade 3/4 AEs of thrombocytopenia, anemia, or hematoma. 4. High risk, intermediate…
Interventions
- DrugMomelotinib
Momelotinib will be administered orally.
- DrugLuspatercept
Luspatercept will be administered subcutaneously.
Locations (33)
- GSK Investigational SiteAnn Arbor, Michigan
- GSK Investigational SiteNew York, New York
- GSK Investigational SiteNashville, Tennessee
- GSK Investigational SiteHouston, Texas
- GSK Investigational SiteSeattle, Washington
- GSK Investigational SiteVancouver, British Columbia