Study on Axatilimab With or Without Azacitidine for Treating Advanced Blood Disorders and High-Risk Leukemia

Sponsor: Uma Borate

Sponsor score: 0

ClinicalTrials ID:NCT06523556

Provider View

This clinical trial is exploring the use of axatilimab, with or without azacitidine, to treat patients with advanced blood disorders and high-risk leukemia. The study aims to find the best dose and assess the effectiveness of these treatments.

Patient Parameters

Program Overview

This study is testing a new treatment using axatilimab, an antibody that targets cancer cells, with or without azacitidine, a drug that slows cancer cell growth. The goal is to see if these treatments are safe and effective for patients with advanced blood disorders like myeloproliferative neoplasms (MPN), MPN/myelodysplastic syndrome (MDS) overlap, or high-risk chronic myelomonocytic leukemia (CMML).

Description

The study has two main phases:

Phase I:

  • Patients receive axatilimab through an IV on days 1 and 15 of each 28-day cycle. This phase aims to find the best dose of axatilimab for patients whose disease has returned or not responded to previous treatments.

Phase II:

  • Patients receive axatilimab and azacitidine, either through an IV or as a shot, over a 28-day cycle. This phase evaluates how well the combination works in newly diagnosed patients. Patients who respond well may continue treatment for up to 24 cycles.

Throughout the study, patients will have regular check-ups, including blood tests and bone marrow biopsies, to monitor their health and the treatment's effects. After finishing the treatment, patients will have follow-up visits for up to two years to track their progress.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of specific advanced blood disorders or high-risk leukemia.
  • Not suitable for intensive chemotherapy due to age or other health conditions.
  • Be in good general health with a performance status of 0, 1, or 2.
  • Have normal liver and kidney function based on specific blood tests.
  • Be able to understand and agree to the study requirements.
  • Women and men of childbearing potential must use effective birth control during the study and for 90 days after the last follow-up visit.

Exclusion Criteria

  • Have received certain previous treatments for MPN or MDS/MPN overlap, except for up to 2 cycles of specific drugs.
  • Have a diagnosis of acute myeloid leukemia (AML).
  • Are candidates for intensive chemotherapy or do not consent to it.
  • Have a history of organ or stem cell transplant.
  • Have a history of other cancers, unless adequately treated and not requiring ongoing therapy.
  • Have known allergies to axatilimab components.
  • Have a history of pancreatitis or muscle inflammation.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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