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New combo aims to free myelofibrosis patients from frequent blood transfusions

NCT ID NCT06517875

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tests whether combining two drugs, momelotinib and luspatercept, can help people with myelofibrosis who need regular blood transfusions. About 68 adults with primary or secondary myelofibrosis will receive the combination orally or by injection. The main goal is to see if they can go at least 12 weeks without needing a transfusion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
momelotinib and luspatercept
What this could lead to
If successful, this combination could reduce or eliminate the need for regular blood transfusions in people with myelofibrosis, improving their quality of life.
What could go wrong
This is an early phase 2 study with only 68 participants, so results may not apply to everyone. The combination may cause side effects or fail to reduce transfusion needs.

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 68 people

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

Started

Feb 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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. 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-2, or intermediate-1 risk as defined by Dynamic International Prognostic Scoring System (DIPSS) \[Passamonti, 2010\] or DIPSS-plus \[Gangat, 2011\]. 5. TD defined as requiring RBC transfusion ≥4 units or HgB \< 8 g/dL in the 8 weeks prior to the first dose of study treatment (NOTE: 2 consecutive Hgb \< 8 g/dL, at least 1 week apart are required; Hgb values impacted by transfusions are excluded). Only transfusions given when Hgb levels are ≤9.5 g/dL are counted towards TD. RBC transfusions given for clinically overt bleeding, or accident/injury (as assessed by the investigator) are not counted towards TD. Exclusion Criteria: 1. History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications. 2. Participants with an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years. 3. Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia. 4. Uncontrolled intercurrent illness: 1. Active uncontrolled infection (participants receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial); 2. Significant active or chronic bleeding event ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to the first dose of study treatment; or 3. Uncontrolled acute and chronic liver disease (e.g., Child-Pugh score ≥10) OR has current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. NOTE: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) is acceptable if participant otherwise meets entry criteria. 5. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, that is not resolved at the time of the first dose of study treatment. 6. Any of the following in conditions within 6 months prior to the first dose of study intervention: 1. Unstable angina pectoris; OR 2. Symptomatic congestive heart failure; OR 3. Uncontrolled cardiac arrhythmia 7. QTc interval \>450 msec or QTc \>480 msec for participants with bundle branch block. 8. Participants with stroke, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to the first dose of study intervention. 9. History of porphyria. 10. Presence of peripheral neuropathy ≥Grade 2 per CTCAE v5.0. 11. Use of the following treatments within the time periods noted NOTE: All active anti-MF therapy must discontinue at least 1 week prior to the start of baseline MFSAF recording (Study Day -7): 1. Active anti-MF therapy within 28 days or 5 half-lives, whichever is shorter (exception is prior JAKi therapy). 2. Steroid use for the treatment of myelofibrosis is prohibited within 14 days prior to the first dose of study treatment until discontinuation of study treatment. Supportive care including steroids for non-myelofibrosis indications may be used. 3. Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of study intervention. 4. Any prior investigational agent for myelofibrosis within 4 weeks prior to the first dose of study treatment. 5. Erythropoiesis stimulating agent (ESA) within 4 weeks prior to the first dose of study treatment. 6. Splenic irradiation within 3 months prior to the first dose of study treatment. 12. Prior treatment with MMB. 13. Prior treatment with TGF-β pathway ligand traps (e.g., luspatercept or sotatercept). 14. Prior splenectomy. 15. Inability or unwillingness to comply with the protocol restrictions on myelofibrosis therapy and other medications prior to and during study treatment. 16. Unresolved non-hematologic toxicities from prior therapies that are \>Grade 1 per CTCAE v5.0 unless otherwise specified. 17. Known positive status for human immunodeficiency virus (HIV). 18. Hepatitis A, B, or C status as defined below: 1. Chronic active or acute viral hepatitis A. 2. Active Hepatitis B infection indicated by the presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of study intervention. 3. Positive hepatitis C antibody test result at screening or within 3 months before the first dose of study intervention. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained. 19. Women who are already pregnant or lactating.

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Conditions

The condition(s) this trial relates to.

primary myelofibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelofibrosis; primary myelofibrosis; post-polycythemia vera myelofibrosis; post-essential thrombocythemia myelofibrosis Primary myelofibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • GSK Investigational Site

    RECRUITING

    New York, New York, 10032, United States

  • GSK Investigational Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    RECRUITING

    Seattle, Washington, 98109, United States

  • GSK Investigational Site

    RECRUITING

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • GSK Investigational Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • GSK Investigational Site

    RECRUITING

    Angers, 49933, France

  • GSK Investigational Site

    RECRUITING

    Brest, 29609, France

  • GSK Investigational Site

    RECRUITING

    Lyon, 69004, France

  • GSK Investigational Site

    RECRUITING

    Nice, 06202, France

  • GSK Investigational Site

    RECRUITING

    Nîmes, 30029, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75010, France

  • GSK Investigational Site

    RECRUITING

    Poitiers, 86021, France

  • GSK Investigational Site

    RECRUITING

    Essen, 45147, Germany

  • GSK Investigational Site

    RECRUITING

    Jena, 07747, Germany

  • GSK Investigational Site

    RECRUITING

    Lübeck, 23538, Germany

  • GSK Investigational Site

    RECRUITING

    Mannheim, 68167, Germany

  • GSK Investigational Site

    RECRUITING

    Bologna, 40138, Italy

  • GSK Investigational Site

    RECRUITING

    Catania, 95123, Italy

  • GSK Investigational Site

    RECRUITING

    Florence, 50134, Italy

  • GSK Investigational Site

    RECRUITING

    Meldola FC, 47014, Italy

  • GSK Investigational Site

    RECRUITING

    Milan, 20122, Italy

  • GSK Investigational Site

    RECRUITING

    Roma, 161, Italy

  • GSK Investigational Site

    RECRUITING

    Badalona, 08005, Spain

  • GSK Investigational Site

    RECRUITING

    Barcelona, 8035, Spain

  • GSK Investigational Site

    RECRUITING

    Las Palmas, 35020, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28009, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28034, Spain

  • GSK Investigational Site

    RECRUITING

    Málaga, 29010, Spain

  • GSK Investigational Site

    RECRUITING

    Valencia, 46026, Spain

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