Myelofibrosis Cancer
Conditions
Interventions
Screening (= 28 days)
?
Momelotinib Alone (Weeks 0–12)
? Week 12 Response Assessment
If Suboptimal ? Add Bomedemstat 50 mg QD
?
Combination Phase (Weeks 12–24)
?
Week 2
Sponsors
United Lincolnshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants =18 years of age on the day of signing informed consent. 2. Histologically confirmed diagnosis of: 2.1. Primary Myelofibrosis (PMF), or 2.2. Secondary MF following Polycythaemia Vera (post-PV MF), or 2.3. Secondary MF following Essential Thrombocythaemia (post-ET MF) (as defined by WHO 2022 criteria) 3. Disease risk category: 3.1. Intermediate-2 or High-risk MF according to DIPSS. 4. Cohort assignment (Investigator-defined; permitted insertion): 4.1. Cohort 1 — Momelotinib-Experienced: 4.1.1. Receiving Momelotinib 200 mg QD for =12 weeks prior to Week 12 assessment 4.1.2. Demonstrates suboptimal response at Week 12 4.2. Cohort 2 — Cytopenic MF: 4.2.1. Baseline Hb <10 g/dL and/or platelets <100 × 10?/L 4.2.2. Starting Momelotinib at Week 0 4.2.3. Demonstrates suboptimal response at Week 12
Exclusion criteria
Exclusion criteria: 1. Medical Conditions 1.1. Known hypersensitivity to Bomedemstat or MAOIs 1.2. Clinically significant GI conditions affecting absorption 1.3. Increased bleeding risk 1.4. Hereditary bleeding disorders 1.5. Active or chronic bleeding within 8 weeks 1.6. Autoimmune bleeding disorders 1.7. Uncontrolled comorbidities 1.8. Active secondary malignancies (with exceptions) 1.9. HBV/HCV/HIV status not meeting template criteria 1.10. Receipt of prohibited medications within 14 days 2. Prohibited Prior Therapies 2.1. Prior treatment with Bomedemstat or other LSD1 inhibitors 2.2. MAOIs or strong CYP3A4 modifiers 2.3. All hematopoietic growth factors (G-CSF, GM-CSF, EPO, TPO mimetics) 2.4. Investigational treatments within 4 weeks Investigator addition permitted: 2.5. Prior treatment with Momelotinib is allowed for Cohort 1 (required) 2.6. Prior treatment with Momelotinib is allowed for Cohort 2 (not required) 2.7. Prior exposure to other JAK inhibitors (e.g., ruxolitinib, fedratinib) is allowed unless associated with severe toxicity 3. Prohibited During Study (Verbatim text from first file retained) 3.1. MAOIs 3.2. Strong inhibitors/inducers of CYP3A4 3.3. Anticoagulants/antiplatelets/NSAIDs when platelets <100 ×10?/L
Countries
England, France, Spain, United Arab Emirates, United Kingdom, United States of America
Contacts
Public ContactCiro Rinaldi
Outcome results
None listed