RecruitingPhase 1Phase 2NCT06523556

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

Phase 1b/2 Study of Axatilimab (SNDX-6352) + Azacitidine (AZA) in Advanced Phase MPN, MPN/MDS Overlap or High-Risk CMML


Sponsor

Uma Borate

Enrollment

52 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib/II trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms (MPN), myeloproliferative neoplasm/myelodysplastic syndrome (MPN/MDS) overlap or high risk chronic myelomonocytic leukemia (CMML). Axatilimab is an antibody that is cloned from a single white blood cell that is known to be able to recognize cancer cells and block a protein on the surface of the white blood cells that may be involved in cancer cell growth. By blocking the proteins, this may slow or halt the growth of the cancer. Azacitidine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells. Giving axatilimab with or without azacitidine may be safe and effective in treating patients with advanced phase MPN, MPN/MDS overlap or high risk CMML.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called axatilimab (with or without a chemotherapy drug called azacitidine) for people with certain rare blood cancers that are in an advanced or high-risk stage. These include conditions where the bone marrow produces too many abnormal blood cells, such as chronic myelomonocytic leukemia (CMML), myeloproliferative neoplasms in accelerated phase, and related overlap disorders. **You may be eligible if...** - You are 18 or older - You have been diagnosed with one of the specific blood cancers listed in this study (such as high-risk CMML, atypical chronic myelocytic leukemia, or myeloproliferative neoplasm in accelerated phase) - Your disease has come back or not responded to prior treatment (Phase 1b), or you are newly diagnosed (Phase 2) - You are not a good candidate for intensive chemotherapy due to age or other health conditions - Your liver, kidney, and overall health function meets the study requirements **You may NOT be eligible if...** - You have already had extensive chemotherapy, azacitidine, or decitabine (more than 2 cycles of certain treatments disqualify you) - You have been diagnosed with acute myeloid leukemia (AML) - You have had an organ transplant or stem cell transplant - You have a history of pancreatitis or myositis - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAxatilimab

Given IV

DRUGAzacitidine

Given IV or SC

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow biopsy and aspiration

OTHERSurvey Administration

Ancillary study


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT06523556


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