Momelotinib for Low-Risk Myelodysplastic Syndrome
This study is looking into momelotinib, a drug, for people with low-risk myelodysplastic syndromes (MDS). MDS is a condition where your bone marrow doesn't make enough healthy blood cells. The main goal is to see if momelotinib can help you become independent from red blood cell transfusions for at least 12 weeks. Researchers will also check for any side effects and how your body handles the drug. About 80 adults, aged 18 and older, with a specific diagnosis of low-risk MDS, can join. The study aims to find the best dose of momelotinib by looking at its effectiveness in reducing transfusion needs and its safety.
- Study design
- This is an interventional study with a planned enrollment of 80 participants. It will involve giving participants different doses of momelotinib.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure red blood cell transfusion independence for up to 24 weeks. Safety will be monitored for up to approximately 109 weeks.
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NCT06847867
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
Recruiting
PHASE2Ages 18+InterventionalTreatmentGlaxoSmithKline
~80 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Momelotinib
At a glance
Recruiting sites
39 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with Red Blood Cells - transfusion independence (RBC-TI) for at least 12 weeks, rolling over 24 weeks
Measured over Up to 24 weeks
+3 more outcomes measured
Conditions
Where it's being run
39 sites across 17 statesSpain8
France5
Italy5
South Korea4
United Kingdom3
California2
Germany2
Arizona1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥18 years or of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent form (ICF).
Documented diagnosis of MDS according to the World Health Organization classifications with an Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease, with an overall risk score ≤3.5 and bone marrow blasts \< 5%.
Received only one prior line of treatment with either Erythropoiesis-stimulating agent (ESA) or luspatercept for LR-MDS-related anemia that is relapsed/refractory to therapy. Participants intolerant OR ineligible to prior ESA or luspatercept will fulfill this inclusion criterion provided the definition below is met.
Refractory to prior treatment: documentation of loss of erythroid (E) response or never achieved HI-E response as defined by the IWG 2018 criteria.
Intolerant to prior treatment: documentation of reasons for discontinuation of prior ESA containing regimen, either as single agent or combination (e.g., G-CSF) or luspatercept due to intolerance or adverse event.
ESA ineligible: low chance of response to ESA based on endogenous serum erythropoietin level \> 200 U/L for participants not previously treated with ESAs.
Red blood cell transfusion dependence, defined as requiring ≥3 units of Packed red blood cells (pRBC) transfused over 16-week period in at least 2 transfusions episodes during the 16 weeks preceding randomization. Documentation of a participant's transfusion policy during this 16-week period is required.
A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
Is a woman of non-childbearing potential (WONCBP). OR
Is a woman of childbearing potential (WOCBP) and using a contraceptive method.
Is capable of giving signed informed consent.
Eastern Cooperative Oncology Group performance status ≤2.
Adequate organ function.
Exclusion
Prior treatment with the following with noted time periods:
Prior allogeneic or autologous stem cell transplant.
Has had any major surgery within 28 days prior to randomization.
Ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline status preceding prior therapy, except if the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.
MDS associated with del 5q cytogenetic abnormality.
MDS/ Myeloproliferative neoplasm (MPN) overlap disorders (e.g., Chronic Myelomonocytic Leukemia \[CMML\]).
Secondary MDS (i.e., MDS that is known to have arisen as the result of chemical injury, treatment with chemotherapy, and/or radiation for other diseases).
Known history of diagnosis of acute myeloid leukemia.
Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia.
Diagnosis of invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years, except as noted below:
Uncontrolled intercurrent illness including, but not limited to:
Any of the following conditions within 6 months prior to randomization:
QTc interval \>480 milliseconds (msec) (corrected using Fridericia formula).
Psychiatric illness, social situation, or any other condition that would limit compliance with trial requirements or may interfere with the interpretation of study results, as judged by investigator or sponsor.
Presence of peripheral neuropathy ≥Grade 2 per CTCAE v5.0.
Known positive status for human immunodeficiency virus (HIV).
Hepatitis B or C status as defined below:
Is unable to swallow and/or retain oral medications.
Known contraindication or hypersensitivity to momelotinib and its metabolites, or any of their excipients.
What this trial measures
- Percentage of participants with Red Blood Cells - transfusion independence (RBC-TI) for at least 12 weeks, rolling over 24 weeksUp to 24 weeks
RBC-TI defined as not requiring RBC transfusions (except in the case of clinically overt bleeding). Percentage of participants with RBC-TI will be measured for any consecutive 12-week interval over 24-week duration.
- Number of participants with Grade 3 Adverse events (AEs), AE leading to treatment discontinuation and AEs leading to dose modificationsUp to approximately 109 weeks
- Maximum plasma concentration (Cmax) of momelotinib and major metabolite of momelotinib (M21)Up to 24 weeks
- Area under the plasma concentration versus time curve (AUC) of momelotinib and M21Up to 24 weeks