Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-05-30

Summary

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) or chronic neutrophilic leukemia (CNL), in addition to standard treatment which usually includes a hypomethylating agent like azacitidine or decitabine. 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. The treatment on this study will include taking momelotinib by mouth for all patients. The first 10 patients may receive momelotinib (MMB) alone for 3 cycles before adding a standard treatment for MDS/MPN called azacitidine (HMA).

The participant may be asked to remain on the treatment for up to 24 months, depending upon how the participant is responding to the study treatment. After the study treatment is completed, the participant will have one additional clinic visit for evaluating overall health, physical examination and blood tests, that will be described later in detail.

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.

• Phase: EARLY_PHASE1

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Azacitidine; Decitabine; N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide