OncoMatch/Clinical Trials/NCT07071155
Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia
Is NCT07071155 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Momelotinib and Azacitidine for chronic myelomonocytic leukemia.
Treatment: Momelotinib · Azacitidine — This research is being done to evaluate effectiveness, safety, and tolerability of a study drug called momelotinib in participants with myelodysplastic/myeloproliferative neoplasms (MDS/MPNs), MDS/MPN-not otherwise specified (MDS/MPN-NOS), MDS/MPN with neutrophilia (MDS/MPN-N), also called as atypical chronic myeloid leukemia, or chronic neutrophilic leukemia. Momelotinib will be added to standard treatment which usually includes a hypomethylating agent like azacitidine. Treatment options for this diagnosis remain limited and investigators need better treatments to help control the disease, improve symptoms, and potentially help more patients become eligible for transplant. Participants for this study will be asked to take some screening tests which will include routine physical examination, blood tests, and imaging scans to determine eligibility for the study. Those who continue to qualify for this study will begin treatment and may be asked to remain on the study drug for up to 24 months, depending upon how they are responding to treatment. After the study drug is completed, patients will have one additional clinic visit to evaluate overall health and response to study drug. The study drug treatment on this study will include taking momelotinib by mouth in combination with azacitidine, which is given by injection for all patients for the first 5 days of each 28-day cycle. The most common side effect that may be related to participation in this study can include (i) infections which can present as fever, chills, cough, breathing problems, diarrhea, vomiting, pain or burning with urination; or (ii) low blood platelet count which can result in bruising or bleeding for longer than usual if the participant hurts themself.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Biomarker criteria
Excluded: SF3B1 mutation
Disease stage
Required: Stage CHRONIC PHASE
Chronic phase disease with <10% blasts in peripheral blood and marrow within 1 month from planned start of treatment
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: JAK inhibitor (momelotinib)
Momelotinib at any time prior to screening
Cannot have received: hypomethylating agent
Exception: If stopped due to side effects >3 months prior to start, allowed; if stopped due to lack of clinical benefit, excluded
Prior lack of response to MMB or hypomethylating agents
Cannot have received: erythropoietic stimulating agent
Exception: Allowed if last treatment >4 weeks prior to start
Erythropoietic stimulating agents within 4 weeks of treatment
Cannot have received: investigational agent
Exception: Allowed if stopped >4 weeks prior to start
Investigational agent within 4 weeks of the first dose of study treatment
Cannot have received: immunosuppressive agent
Exception: Low dose steroids ≤10 mg daily prednisone or equivalent is allowed
Immunosuppressive agents within 28 days (low dose steroids ≤10 mg daily prednisone or equivalent is allowed)
Cannot have received: strong CYP3A4 inducer
Exception: Rifampin and rifampicin excepted
Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of momelotinib
Lab requirements
Blood counts
platelets ≥25,000/microL, ANC ≥0.75 x 10^9/L (without transfusion or growth factor support), albumin ≥2.5 g/dL
Kidney function
creatinine clearance measured by Cockcroft-Gault calculation ≥30 mL/min
Liver function
total bilirubin ≤1.5×ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), AST or ALT ≤2.5 x ULN (≤5 x ULN if liver involved by extramedullary hematopoiesis or related to iron chelator therapy started within prior 60 days)
Blood counts with platelets ≥25,000/microL, ANC ≥0.75 x 10^9/L (without transfusion or growth factor support); Adequate organ function with creatinine clearance measured by Cockcroft-Gault calculation ≥30 mL/min, total bilirubin ≤1.5×ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), INR ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range of intended use of anticoagulants, albumin ≥2.5 g/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland
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