Phase I/II Study of Axatilimab and Ruxolitinib for Treating Myelofibrosis and Chronic Myelomonocytic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07128381

Provider View

This clinical trial is testing a new treatment using axatilimab, a monoclonal antibody, in combination with ruxolitinib to see if it can help control myelofibrosis (MF) and chronic myelomonocytic leukemia (CMML). The study aims to find the best dose and evaluate the treatment's effectiveness and safety.

Patient Parameters

Program Overview

The study is designed to find the best dose of axatilimab, both alone and when combined with ruxolitinib, for treating patients with myelofibrosis (MF) and chronic myelomonocytic leukemia (CMML). Researchers want to see if this combination can effectively manage these conditions. The trial will also monitor any side effects and measure how well the treatment works in reducing symptoms and improving patients' health.

Description

This clinical trial is divided into two phases. In Phase I, the focus is on finding a safe and effective dose of axatilimab, both alone and with ruxolitinib, for patients with myelofibrosis (MF) and chronic myelomonocytic leukemia (CMML). Researchers will assess the safety and tolerability of the treatment and determine the maximum dose that patients can handle without severe side effects. In Phase II, the study will expand to evaluate how well the treatment works in controlling the diseases, looking at the overall response rate, which includes complete and partial remissions and other clinical benefits.

For CMML, the study will also look at how long patients respond to the treatment, their survival without leukemia, and overall survival. It will assess improvements in symptoms and changes in blood and bone marrow markers. For MF, researchers will explore the time it takes for patients to respond to the treatment, how long the response lasts, and any changes in bone marrow fibrosis and genetic markers.

Participants will be closely monitored for any side effects, and their health will be regularly assessed to ensure the treatment is safe and effective.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, as MF and CMML are rare in children.
  • Diagnosed with myelofibrosis (MF) or chronic myelomonocytic leukemia (CMML).
  • For MF: Must have had at least one prior therapy or a suboptimal response to a JAK inhibitor.
  • For CMML: Must have tried other treatments like hydroxyurea or hypomethylating agents without success.
  • Must be in good general health with a performance status of 2 or less.
  • Must have adequate liver and kidney function based on specific blood tests.
  • Women of childbearing potential must agree to use effective birth control during the study.
  • Must be willing to sign an informed consent form and comply with study procedures.

Exclusion Criteria

  • Currently receiving treatment for another cancer, except for certain non-threatening types.
  • Taking other investigational drugs or have used CSF1-R inhibitors before.
  • Have active, uncontrolled infections or tuberculosis.
  • Have conditions that affect the absorption of medications.
  • Have a history of pancreatitis or active muscle inflammation.
  • Have a low platelet count unless related to MF or CMML treatment.
  • Pregnant or breastfeeding women are excluded due to potential risks to the baby.
  • Unwilling to follow birth control requirements during the study.
  • Have a history of hepatitis B or C, or HIV due to potential risks with JAK inhibitor therapy.
  • Have severe heart conditions or recent heart attacks.
  • Have psychiatric or social issues that would prevent following the study requirements.

Locations

FACILITYZIPCITYSTATE
The University of Texas M. D. Anderson Cancer Center77030HoustonTexas

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