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Momelotinib with Azacitidine for Myelodysplastic/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia

This study is testing momelotinib in combination with azacitidine for people with certain blood cancers, including chronic myelomonocytic leukemia (CMML), myelodysplastic/myeloproliferative overlap neoplasms (MDS/MPN), and chronic neutrophilic leukemia (CNL). Researchers want to see how safe and effective this combination treatment is. Momelotinib is given as a capsule by mouth once a day, and azacitidine is given as an injection. The goal is to find better ways to control these diseases, improve symptoms, and potentially help more patients become eligible for a transplant. The study will measure how many participants have a complete response, partial response, or overall clinical benefit after 24 weeks of treatment. You must be at least 18 years old and have one of the listed diagnoses to be eligible.

Study design
This is an open-label study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll up to 18 participants.
What's involved
You would take momelotinib capsules by mouth once a day for up to 24 months, depending on how you respond to treatment. Azacitidine is given on days 1-5 in a 28-day cycle.
Compensation
Not stated in the trial record.
Follow-up
The study measures treatment responses at 24 weeks, but does not specify how long you would be followed after treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07071155

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~18 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:MomelotinibAzacitidine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants who achieve a complete response
Measured over 24 weeks
+2 more outcomes measured

Conditions

Chronic Myelomonocytic Leukemia
Myelodysplastic Syndromes
Myeloproliferative Overlap Neoplasms
Chronic Neutrophilic Leukemia

Explore related trials

Chronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaMiller-Dieker Syndrome

NCT07071155

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tania Jain, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who to contact

Tania Jain, MD
[email protected]
410-955-7035
Email the study team

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Eligibility criteria

Exclusion

Diagnosis of MDS/MPN with SF3B1 gene mutation and thrombocytosis (excluded due to unclear role of ACRV1 in the development of anemia)
Peripheral blood or marrow (by immunohistochemistry) blast percentage \>10%
Prior lack of response to MMB or hypomethylating agents.
Known history of allergic reaction to momelotinib
AST or ALT above 2.5 x ULN (above 5 X ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)
The following treatments within the time periods as specified:
Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo any imaging (ultrasound, CT without contrast or MRI without contrast) for spleen volume measurement per requirements
Patients with an active invasive concurrent malignancy, whose natural history or treatment has a significant potential to interfere with the safety or efficacy assessment of the investigational regimen.
Localized prostate cancer that has been treated surgically or by radiotherapy with curative intent and presumed cured is allowed.
History of non-melanoma skin cancers such as basal cell carcinoma or squamous cell carcinoma are also allowed.
Completely resected intraepithelial carcinoma of cervix or papillary thyroid or follicular thyroid cancers are also allowed at the investigator's discretion.
Untreated or active infections are excluded as below:
Nonhematologic toxicities from prior therapies that are unresolved and are of grade \>1
Presence of peripheral neuropathy of grade ≥2
Pregnant women are excluded from this study because the effects of momelotinib on embryotoxicity, survival, and teratogenicity remain unclear.
Patients unable to swallow medications
Patient has any medical condition that puts the patient at an acceptable high risk with participation in the study per physician assessment or has any condition that confounds the ability to interpret data from the study.
Any major surgery or radiation or intervention that interferes with safety or feasibility of enrollment per investigator assessment

What this trial measures

  • Number of participants who achieve a complete response24 weeks

    Efficacy determination - complete response: number of participants who achieve a complete response as defined by international consortium response criteria for MDS/MPN in adults

  • Number of participants who achieve a partial response24 weeks

    Efficacy determination - partial response: number of participants who achieve a partial response as defined by international consortium response criteria for MDS/MPN in adults

  • Number of participants who achieve a clinical benefit24 weeks

    Efficacy determination - clinical benefit: number of participants who achieve a clinical benefit per MDS/MPN IWG criteria4