Baltimore, MDNCT07071155Now EnrollingIRB Ready

Chronic Myelomonocytic Leukemia Clinical Trial in Baltimore, MD

Access cutting-edge chronic myelomonocytic leukemia treatment through this early phase 1 clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Expert Care in Baltimore

Access chronic myelomonocytic leukemia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic myelomonocytic leukemia treatment provided free

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Check if you qualify for this chronic myelomonocytic leukemia clinical trial in Baltimore, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Chronic Myelomonocytic Leukemia Study in Baltimore

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.

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who Can Participate

Inclusion Criteria

Patients of age 18 or older
Has a diagnosis of MDS/MPN or CNL by WHO or ICC diagnostic criteria:
Chronic myelomonocytic leukemia
MDS/MPN with neutrophilia, previously known as atypical chronic myeloid leukemia
Chronic neutrophilic leukemia
MDS/MPN -not otherwise specified
Chronic phase disease with \<10% blasts in peripheral blood and marrow within 1 month from planned start of treatment
Eastern Cooperative Oncology Group (ECOG) Performance Score44 of 0-2
Patients can be treatment naïve or could have undergone prior treatments for MDS/MPN as below:
Prior treatment with non-JAK inhibitors or hypomethylating agents are allowed (e.g., hydroxyurea, immunomodulatory agents, steroids). Hydroxyurea can be continued until or even beyond initiation of treatment for 2 months if needed for cytoreduction
If non-MMB JAK inhibitors were used for treatment and stopped due to side effects (e.g., anemia from ruxolitinib, gastrointestinal toxicity from fedratinib, etcetera), these patients will be allowed to enroll on this study as long as JAK inhibitor was stopped at least 2 weeks prior to anticipated start date of treatment
If prior hypomethylating agent was used and stopped longer than 3 months prior to anticipated start date of treatment due to side effects, these patients will be eligible. However, if hypomethylating agents were stopped due to lack of clinical benefit, these patients will not be deemed eligible
Prior treatment with erythropoietic stimulating agents is allowed if last treatment was more than 4 weeks prior to anticipated start date of treatment
Splenic radiation should have been performed more than 2 months before anticipated start date of treatment
Any prior or ongoing investigation therapy or agents should be stopped longer than 4 weeks of anticipated start date of treatment
Blood counts with platelets ≥25,000/microL, ANC ≥0.75 x 10\^9/L (without transfusion or growth factor support)
Baseline splenomegaly with ≥5 cm below costal margin or ≥450 cm3 on imaging (ultrasound, CT or MRI)
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.
Willing and able to sign the informed consent form
Life expectancy \> 24 weeks
Willing and able to complete patient-reported outcome assessments using an ePRO device according to protocol
Patients of child-bearing potential, or those with partners of child-bearing potential or pregnant or lactating partners, who are willing to follow highly effective contraceptive requirements. Females of reproductive potential should use effective contraception during study treatment and for 6 months following the last dose for HMA-MMB and 1 week following the last dose for MMB monotherapy. Males with female partners of reproductive potential should use effective contraception during study treatment and for 3 months following the last dose for HMA-MMB and 1 week following the last dose for MMB monotherapy. Patients should not breastfeed during treatment and for 1 week after the last dose.
Patients of child-bearing potential with a negative highly sensitive serum pregnancy test within 24 hours before the first dose of momelotinib. Exclusion criteria
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:
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

Exclusion Criteria

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:
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07071155) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Myelomonocytic Leukemia Treatment Options in Baltimore, MD

If you're searching for chronic myelomonocytic leukemia treatment options in Baltimore, MD, this clinical trial (NCT07071155) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this early phase 1 clinical trial. You'll receive care from experienced chronic myelomonocytic leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic myelomonocytic leukemia clinical trials near you to find additional studies recruiting in your area.

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