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New combo therapy aims to shrink enlarged spleens in bone marrow cancer patients

NCT ID NCT07424950

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 99 years

Sex

Anyone

Healthy volunteers

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

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

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