Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07424950
Eligibility Criteria:
Inclusion Criteria:
* 1\. Male or female participants ≥18 years of age on the day of signing informed consent.
2\. Histologically confirmed diagnosis of:
* Primary Myelofibrosis (PMF), or
* Secondary MF following Polycythaemia Vera (post-PV MF), or
* Secondary MF following Essential Thrombocythaemia (post-ET MF) (as defined by WHO 2022 criteria) 3. Disease risk category:
* Intermediate-2 or High-risk MF according to DIPSS. 4. Cohort assignment (Investigator-defined; permitted insertion):
Cohort 1 - Momelotinib-Experienced:
* Receiving Momelotinib 200 mg QD for ≥12 weeks prior to Week 12 assessment
* Demonstrates suboptimal response at Week 12 (definition below)
Cohort 2 - Cytopenic MF:
* Baseline Hb \<10 g/dL and/or platelets \<100 × 10⁹/L
* Starting Momelotinib at Week 0
* Demonstrates suboptimal response at Week 12
Exclusion Criteria:
5.2.1 Medical Conditions
* Known hypersensitivity to Bomedemstat or MAOIs
* Clinically significant GI conditions affecting absorption
* Increased bleeding risk
* Hereditary bleeding disorders
* Active or chronic bleeding within 8 weeks
* Autoimmune bleeding disorders
* Uncontrolled comorbidities
* Active secondary malignancies (with exceptions)
* HBV/HCV/HIV status not meeting template criteria
* Receipt of prohibited medications within 14 days (All text unchanged.)
5.2.2 Prohibited Prior Therapies
* Prior treatment with Bomedemstat or other LSD1 inhibitors
* MAOIs or strong CYP3A4 modifiers
* All hematopoietic growth factors (G-CSF, GM-CSF, EPO, TPO mimetics)
* Investigational treatments within 4 weeks
Investigator addition permitted:
* Prior treatment with Momelotinib is allowed for Cohort 1 (required)
* Prior treatment with Momelotinib is allowed for Cohort 2 (not required)
* Prior exposure to other JAK inhibitors (e.g., ruxolitinib, fedratinib) is allowed unless associated with severe toxicity
5.2.3 Prohibited During Study (Verbatim text from first file retained)
* MAOIs
* Strong inhibitors/inducers of CYP3A4
* Anticoagulants/antiplatelets/NSAIDs when platelets \<100 ×10⁹/L
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT07424950
Study Brief:
Protocol Section:
NCT07424950