Actively Recruiting
Momelotinib During and After HCT in Myelofibrosis
Led by Massachusetts General Hospital · Updated on 2026-03-31
28
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, open-label, phase I study to determine the safety and tolerability of momelotinib in patients with myelofibrosis during and after hematopoietic cell transplantation (HCT).
CONDITIONS
Official Title
Momelotinib During and After HCT in Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed primary or secondary myelofibrosis according to standard criteria.
- Disease risk must be intermediate-2 or high risk by DIPSS Plus, or intermediate-1 with specific unfavorable features.
- Participants may or may not be on JAK inhibitor therapy; those on other JAK inhibitors must switch to momelotinib starting Day -7 before transplant.
- Age must be over 18 years.
- Participants must be planned for allogeneic HCT using reduced intensity conditioning and peripheral blood stem cells.
- Eligible donors include fully matched related or unrelated donors at the allele level.
- ECOG performance status must be 2 or lower (Karnofsky 60% or higher).
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and shortly after the study.
- Male participants with partners of childbearing potential must agree to use acceptable birth control methods during and after the study.
- Participants must be able and willing to provide informed consent.
You will not qualify if you...
- Known intolerance or allergy to any JAK inhibitor including momelotinib or its components.
- Major surgery within 28 days before study start.
- Use of investigational drugs within 4 weeks prior to study treatment.
- Use of immunosuppressive agents within 28 days prior to study treatment.
- Prior allogeneic transplant for any blood disorder.
- History of accelerated phase or leukemic transformation with 10% or more blasts in bone marrow before transplant.
- Active, uncontrolled infections.
- Liver disease with complications such as ascites, encephalopathy, coagulopathy, or jaundice.
- Active hepatitis B or C infection.
- History of other cancers unless disease-free for 2 years or low risk for progression.
- Abnormal liver or kidney function beyond specified limits.
- Heart failure class 3 or 4 or significant heart dysfunction or arrhythmia not controlled by treatment.
- Unable to take oral medications or with gastrointestinal conditions affecting absorption.
- Peripheral neuropathy of grade 2 or higher.
- Pregnant or breastfeeding women or those unwilling to use effective contraception.
- Men unwilling to use birth control or refrain from sperm donation during and after study.
- Use of strong CYP 3A4 inducers during the study.
- Donors with major ABO blood group mismatch only.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
G
Gabriela Hobbs, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here