OncoMatch/Clinical Trials/NCT06847867
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome
Is NCT06847867 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Momelotinib for myelodysplastic syndromes.
Treatment: Momelotinib — The goal of this clinical trial is to determine if momelotinib is safe and effective for people with low-risk myelodysplastic syndromes (LR-MDS). The trial will also examine how the body processes the drug. The study is comprised of two parts: Part 1: Participants will receive different doses of momelotinib to find the best dose by evaluating effectiveness in improving red blood cell transfusion requirements and safety. Part 2: Participants will receive dose selected from Part 1 to assess its impact on improving red blood cell transfusion requirements and safety in LR-MDS.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage VERY LOW, LOW, INTERMEDIATE (IPSS-R)
IPSS-R classification of very low, low, or intermediate risk disease, with an overall risk score ≤3.5
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: erythropoiesis-stimulating agent (erythropoiesis-stimulating agent, luspatercept) — for LR-MDS-related anemia
Received prior treatment with Erythropoiesis-stimulating agent (ESA) OR luspatercept for LR-MDS-related anemia that is relapsed/refractory to therapy. Participants intolerant to prior ESA or luspatercept will fulfill this inclusion criterion provided the definition below is met.
Cannot have received: JAK1/2 inhibitor
Prior treatment with Janus kinase (JAK)1/2 inhibitors
Cannot have received: ACTRIIb IMiDs
Exception: if ≤1 week of treatment received; provided last dose was ≥8 weeks from randomization
ACTRIIb IMiDs (if ≤1 week of treatment received; provided last dose was ≥8 weeks from randomization)
Cannot have received: ACTRIIb receptor ligand trap other than luspatercept
ACTRIIb receptor ligand trap other than luspatercept
Cannot have received: hypomethylating agent
Hypomethylating agents or other disease modifying agents (i.e., IMiDs) and immunosuppressive therapy for MDS
Cannot have received: immunomodulatory drug
Hypomethylating agents or other disease modifying agents (i.e., IMiDs) and immunosuppressive therapy for MDS
Cannot have received: immunosuppressive therapy
Hypomethylating agents or other disease modifying agents (i.e., IMiDs) and immunosuppressive therapy for MDS
Cannot have received: erythropoiesis-stimulating agent
Exception: within 4 weeks, or 8 weeks for long-acting ESA
ESA within 4 weeks, or 8 weeks for long-acting ESA
Cannot have received: growth factor (G-CSF, GM-CSF)
Exception: within 4 weeks
Growth factors (i.e., G-CSF, GM-CSF) within 4 weeks
Cannot have received: (luspatercept)
Exception: within 8 weeks
Luspatercept within 8 weeks
Cannot have received: investigational agent
Exception: within 4 weeks or 5 half-lives, whichever is longer
Investigational agents within 4 weeks or 5 half-lives, whichever is longer
Cannot have received: corticosteroid
Exception: for treatment of the underlying disease within 28 days. Supportive care use of steroids for non-MDS indications may be used provided participant is on a stable dose equivalent to ≤10 mg prednisone per day.
Corticosteroids for treatment of the underlying disease within 28 days. Supportive care use of steroids for non-MDS indications may be used provided participant is on a stable dose equivalent to ≤10 mg prednisone per day.
Cannot have received: anti-MDS therapy
Exception: not otherwise listed within 28 days or 5 half-lives whichever is longer
Other active anti-MDS therapy not otherwise listed within 28 days or 5 half-lives whichever is longer
Cannot have received: stem cell transplant (allogeneic stem cell transplant, autologous stem cell transplant)
Prior allogeneic or autologous stem cell transplant
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- GSK Investigational Site · Canton, Ohio
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