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

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 5, 2025

Primary Completion Date

November 5, 2027

Study Completion Date

May 30, 2028

Conditions
Chronic Myelomonocytic LeukemiaMyelodysplastic SyndromesMyeloproliferative Overlap NeoplasmsChronic Neutrophilic Leukemia
Interventions
DRUG

Momelotinib

The investigators will randomize the first 10 patients to receive 200 mg momelotinib (MMB) monotherapy for first 3 cycles with addition of HMA starting cycle 4 (Arm A, n=5) versus starting with MMB-HMA combination both starting in cycle 1 (Arm B, n=5). The regimen used for the next 8 patients (Arm C- expansion) will be determined after an interim analysis of Arms A and B at week 12 after the first 10 participants have been randomized.

DRUG

Azacitidine

75 mg/m2, days 1-5 in a 28-day cycle

DRUG

Decitabine

20mg/m2, days 1-5 in a 28-day cycle

All Listed Sponsors
lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER