Actively Recruiting
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Led by GlaxoSmithKline · Updated on 2026-04-20
68
Participants Needed
33
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or Post-polycythemia vera (PV)/ essential thrombocythemia (ET) myelofibrosis (MF) who are either janus kinase (JAK) inhibitor (JAKi) naïve or experienced.
CONDITIONS
Official Title
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of primary myelofibrosis by WHO 2016 criteria or post-polycythemia vera/essential thrombocythemia myelofibrosis by IWG-MRT criteria
- Janus kinase inhibitor naive or previously treated with ruxolitinib or fedratinib for at least 90 days, or 28 days if complicated by transfusion needs or severe side effects
- Classified as high risk, intermediate-2, or intermediate-1 risk by DIPSS or DIPSS-plus
- Transfusion dependent, needing 4 or more units of red blood cells or having hemoglobin less than 8 g/dL in the 8 weeks before starting study treatment (with specific criteria for hemoglobin levels and transfusion counting)
You will not qualify if you...
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or gastrointestinal conditions affecting medication absorption or swallowing
- Invasive malignancy or history of invasive cancer other than study disease within last 5 years
- Significant anemia from iron, vitamin B12, folate deficiencies, autoimmune/hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia
- Uncontrolled illness such as active infection, significant bleeding within 4 weeks prior to study, or unstable liver disease
- Uncontrolled hypertension not resolved at study start
- Unstable angina, symptomatic heart failure, or uncontrolled arrhythmia within 6 months prior to study
- QTc interval above specified limits
- Stroke, deep vein thrombosis, or embolism within 6 months prior to study
- History of porphyria
- Peripheral neuropathy grade 2 or higher
- Recent use of active anti-myelofibrosis therapy, steroids for myelofibrosis, certain CYP3A4 inducers, investigational agents, erythropoiesis stimulating agents, or splenic irradiation
- Prior treatment with momelotinib, TGF-beta pathway ligand traps, or splenectomy
- Inability or unwillingness to follow study therapy and medication restrictions
- Unresolved toxicities above grade 1 from prior therapies
- Known positive HIV status
- Active or chronic hepatitis A, B, or C infection
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
GSK Investigational Site
New York, New York, United States, 10032
Actively Recruiting
3
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
GSK Investigational Site
Houston, Texas, United States, 77030
Actively Recruiting
5
GSK Investigational Site
Seattle, Washington, United States, 98109
Actively Recruiting
6
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
7
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
8
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
9
GSK Investigational Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
10
GSK Investigational Site
Angers, France, 49933
Actively Recruiting
11
GSK Investigational Site
Brest, France, 29609
Actively Recruiting
12
GSK Investigational Site
Lyon, France, 69004
Actively Recruiting
13
GSK Investigational Site
Nice, France, 06202
Actively Recruiting
14
GSK Investigational Site
Nîmes, France, 30029
Actively Recruiting
15
GSK Investigational Site
Paris, France, 75010
Actively Recruiting
16
GSK Investigational Site
Poitiers, France, 86021
Actively Recruiting
17
GSK Investigational Site
Essen, Germany, 45147
Actively Recruiting
18
GSK Investigational Site
Jena, Germany, 07747
Actively Recruiting
19
GSK Investigational Site
Lübeck, Germany, 23538
Actively Recruiting
20
GSK Investigational Site
Mannheim, Germany, 68167
Actively Recruiting
21
GSK Investigational Site
Bologna, Italy, 40138
Actively Recruiting
22
GSK Investigational Site
Catania, Italy, 95123
Actively Recruiting
23
GSK Investigational Site
Florence, Italy, 50134
Actively Recruiting
24
GSK Investigational Site
Meldola FC, Italy, 47014
Actively Recruiting
25
GSK Investigational Site
Milan, Italy, 20122
Actively Recruiting
26
GSK Investigational Site
Roma, Italy, 161
Actively Recruiting
27
GSK Investigational Site
Badalona, Spain, 08005
Actively Recruiting
28
GSK Investigational Site
Barcelona, Spain, 8035
Actively Recruiting
29
GSK Investigational Site
Las Palmas, Spain, 35020
Actively Recruiting
30
GSK Investigational Site
Madrid, Spain, 28009
Actively Recruiting
31
GSK Investigational Site
Madrid, Spain, 28034
Actively Recruiting
32
GSK Investigational Site
Málaga, Spain, 29010
Actively Recruiting
33
GSK Investigational Site
Valencia, Spain, 46026
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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