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Chronic Myelomonocytic LeukemiaEarly Phase 1M-HArbOrNCT07071155

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

A Early Phase 1 study testing Momelotinib and Azacitidine in people with Chronic Myelomonocytic Leukemia and Myelodysplastic Syndromes, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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), MDS/MPN-not otherwise specified (MDS/MPN-NOS), MDS/MPN with neutrophilia (MDS/MPN-N), also called as atypical chronic myeloid… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Momelotinib and Azacitidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
19 Mar 2026to 30 Jul 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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:
Show all 26Show fewer
  • Momelotinib at any time prior to screening
  • Erythropoietic stimulating agents within 4 weeks of treatment
  • Investigational agent within 4 weeks of the first dose of study treatment
  • Immunosuppressive agents within 28 days (low dose steroids ≤10 mg daily prednisone or equivalent is allowed)
  • Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of momelotinib. Strong CYP3A4 inducers can lead to decreased MMB exposure and risk a lack of efficacy. Therefore, alternative medicinal product to strong CYP3A4 inducer should be considered.
  • 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:
  • Chronic active or acute viral hepatitis A, B, or C infection. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C RNA test is obtained.
  • HIV with CD4+ cell count under 400 cells/ μL or on treatment with anti-retroviral therapy that is specifically excluded per the criteria above. HIV patients on established anti-retroviral therapy allowed per protocol for at least 4 weeks and CD4+ count above or equal to 400 cells/ μL
  • Infections requiring intravenous antibiotics
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tania Jain, MD contact

410-955-7035

tjain2@jhmi.edu

Amanda Stevens, MD CCRA contact

msteve35@jhmi.edu

United States1 site, 1 recruiting

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

    Tania Jain, MBBS, 410-955-7035, tjain2@jhmi.edu

    Mary Amanda Stevens, MD, msteve35@jhmi.edu

    Recruiting

Other trials in United States

About this study

Official title: A Pilot Study of Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia (M-HArbOr)

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.

Read the detailed description

This is an open-label study of MMB-HMA in MDS/MPN and CNL that will enroll up to 18 patients. Momelotinib will be administered using modified 3+3 dose escalation design followed by expansion. The first three patients will be treated at 150mg daily and if DLT criteria are not met, the remaining patients will be treated at 200mg daily to a total of 18 evaluable patients (all in combination with azacitidine). If DLTs are met within the dose escalation phase (first three patients), then the patients will be treated at 150mg daily (in combination with azacitidine)

Key Eligibility Criteria:

  1. Patients with a WHO diagnosis of chronic myelomonocytic leukemia (CMML), MDS/MPN-not otherwise specified (MDS/MPN-NOS), MDS/MPN with neutrophilia (MDS/MPN-N), CNL.
  2. Age greater than or equal to 18 years
  3. Blood counts with platelets greater than 25,000/microL, ANC greater than or equal to 0.75 x 10^9/L (without transfusion or growth factor support)
  4. Baseline splenomegaly with greater than or equal to 5 cm below costal margin or greater than or equal to 450 cm3 on imaging (ultrasound, CT or MRI)
Being tested
Momelotinib, Azacitidine
Keywords
momelotinib, chronic neutrophilic leukemia, myelodysplastic, myeloproliferative
Medical subject headings
Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes, Leukemia, Neutrophilic, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MomelotinibDrug

    Also called OJJAARA

    Capsules of Momelotinib will be administered orally once a day by all participants for up to 24 months, depending on response to treatment.

    Dose escalation will include the first 3 patients who will receive either 150 mg or 200mg of momelotinib daily, depending on the number of dose limiting toxicities (DLTs) experienced during this period.

    Dose expansion will include up to 18 evaluable participants who will receive the maximum tolerated dose (either 150mg or 200 mg) daily as will be determined during the dose escalation phase.

  • AzacitidineDrug

    Also called Vidaza

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

Study groups in NCT07071155
Study groupRoleWhat they receive
Combination therapy (MMB-HMA)ExperimentalCombination of once daily oral momelotinib plus hypomethylating agents (HMA), e.g. azacitidine) starting cycle 1. Azacitidine will be administered as an injection at 75 mg/m2 for days 1-5 in a 28-day cycle. Dose escalation Phase: The first 3 patients will receive MMB 150 mg daily in combination with azacitidine. Depending on the number of dose limiting toxicities (DLTs) experienced during this period, participants in this phase of the study will receive either 150mg daily or have an escalated dose of 200mg daily. Depending on DLT assessment during this phase of the study, the maximum tolerated dose (MTD) of either 150mg or 200mg will be determined. Expansion Phase: Once the MTD is determined (either 150 mg or 200 mg), all remaining patients up to the total of 18 evaluable patients will be treated at the MTD.
Receives: Drug: Momelotinib; Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who achieve a complete response

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

    Measured: 24 weeks

  2. Number of participants who achieve a partial response

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

    Measured: 24 weeks

  3. Number of participants who achieve a clinical benefit

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

    Measured: 24 weeks

Secondary outcomes (11)

  1. Number of participants who experience a grade 3 or higher adverse events or severe event

    Safety and tolerability evaluation: number of participants who experience a grade 3 or higher adverse event events or severe adverse events as defined by CTCAE v.5.0

    Measured: 2 years

  2. Number of Participants Who Achieve Erythroid Response

    Number of patients who achieve erythroid response at week 12 per international consortium criteria

    Measured: 12 weeks

  3. Number of Participants Who Achieve Erythroid Response

    Number of participants who achieve erythroid response at week 24 per international consortium criteria

    Measured: 24 weeks

  4. Proportion of Participants Who Achieve Spleen Size Reduction

    Determine the proportion of participants who achieve a spleen volume reduction of ≥ 35% from baseline at week 12

    Measured: 12 weeks

  5. Proportion of participants Who Achieve Spleen Size Reduction

    Determine the proportion of participants who achieve a spleen volume reduction of ≥ 35% from baseline at week 24

    Measured: 24 weeks

  6. Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)

    Evaluate efficacy of momelotinib plus hypomethylating agents azacitidine or decitabine (MMB-HMA) on MPN-SAF TSS questionnaire. Score range 0-100, higher score worse symptoms.

    Measured: 12 weeks

  7. Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)

    Evaluate efficacy of momelotinib plus hypomethylating agents azacitidine or decitabine (MMB-HMA) on MPN-SAF TSS questionnaire. Score range 0-100, higher score worse symptoms.

    Measured: 24 weeks

  8. Patient Global Impression of Change (PGIC) questionnaire

    Evaluate efficacy of momelotinib plus hypomethylating agents azacitidine or decitabine (MMB-HMA) on Patient Global Impression of Change (PGIC) questionnaire. A 7-point scale (1-7) rating of overall improvement. Patients rate their change as 1="very much improved," 2="much improved," 3="minimally improved," 4="no change," 5="minimally worse," 6="much worse," or 7="very much worse." Lower values represent a better outcome.

    Measured: 12 weeks

  9. Patient Global Impression of Change (PGIC)

    Evaluate efficacy of momelotinib plus hypomethylating agents azacitidine or decitabine (MMB-HMA) on Patient Global Impression of Change (PGIC) questionnaire. A 7-point scale (1-7) rating of overall improvement. Patients rate their change as 1="very much improved," 2="much improved," 3="minimally improved," 4="no change," 5="minimally worse," 6="much worse," or 7="very much worse." Lower values represent a better outcome.

    Measured: 24 weeks

  10. Trough concentrations of MMB as single agent and in combination with HMA

    Evaluate trough concentrations at week 12 in Arm A and B

    Measured: 12 weeks

  11. Trough concentrations of MMB as single agent and in combination with HMA

    Evaluate trough concentrations at week 24 in Arm A and B

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2025
  2. Study start19 Mar 2026
  3. Primary completion5 Mar 2028 (estimated)
  4. Study completion30 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label study of MMB-HMA in MDS/MPN and CNL. The investigators will enroll a total of 18 evaluable patients using a modified 3+3 dose escalation design followed by expansion.
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07071155
Sponsor's protocol ID
J2586
Other IDs
IRB00509021
Acronym
M-HArbOr
Status last verified
Mar 2026
First submitted
9 Jul 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Momelotinib and Azacitidine in people with Chronic Myelomonocytic Leukemia and Myelodysplastic Syndromes, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tania Jain, MD (410-955-7035, tjain2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who achieve a complete response (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07071155.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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