Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
NCT ID: NCT06517875
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
56 participants
INTERVENTIONAL
2025-02-28
2026-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Momelotinib + Luspatercept
Participants with transfusion dependent primary myelofibrosis or post- PV/ ET myelofibrosis that is JAKi naïve or JAKi experienced will receive momelotinib and luspatercept.
Momelotinib
Momelotinib will be administered orally.
Luspatercept
Luspatercept will be administered subcutaneously.
Interventions
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Momelotinib
Momelotinib will be administered orally.
Luspatercept
Luspatercept will be administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. 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
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. 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 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Nashville, Tennessee, United States
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Angers, , France
GSK Investigational Site
Brest, , France
GSK Investigational Site
Lyon, , France
GSK Investigational Site
Nice, , France
GSK Investigational Site
Nîmes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Poitiers, , France
GSK Investigational Site
Florence, , Italy
GSK Investigational Site
Roma, , Italy
GSK Investigational Site
Málaga, , Spain
GSK Investigational Site
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-518225-15
Identifier Type: REGISTRY
Identifier Source: secondary_id
220752
Identifier Type: -
Identifier Source: org_study_id