New combo therapy aims to shrink enlarged spleens in bone marrow cancer patients
NCT ID NCT07424950
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding bomedemstat to the standard drug momelotinib can help people with myelofibrosis, a type of bone marrow cancer. It is for patients whose spleen is still enlarged after 12 weeks on momelotinib alone. The main goal is to see if the combination reduces spleen size by at least 35% after 24 weeks of treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Half-Matched stem cells tested as cure for myelofibrosis
- Can blood tests predict transplant complications?
- Can a new daily pill shrink the spleen and ease myelofibrosis symptoms?
- Can a new pill tame myelofibrosis?
- MRI as a window into bone marrow disease: a new biomarker test?
- Can a menin inhibitor tame myelofibrosis when standard drugs fall short?