Health Trials

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

ConditionsAtypical Chronic Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic/Myeloproliferative NeoplasmRecurrent Myelodysplastic/Myeloproliferative NeoplasmRecurrent Myeloproliferative NeoplasmRefractory Chronic Myelomonocytic LeukemiaRefractory Myelodysplastic/Myeloproliferative NeoplasmRefractory Myeloproliferative Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUma Borate

About this trial

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 criteria

Qualifiers

Signed informed consent must be obtained prior to participation in the study

Age ≥ 18 years at the date of signing the informed consent form (ICF)

Chronic myelomonocytic leukemia (CMML), classified as intermediate-2, OR high-risk per the CMML Specific Prognostic Scoring System (CPSS) Molecular Model

Atypical chronic myelocytic leukemia (aCML)

Disqualifiers

Previous treatment for MPN or MDS/MPN overlap with chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine or INQOVI (oral decitabine) (patients who had up to 2 cycles of hypomethylating agents [HMAs] can be included). However, previous treatment with hydroxyurea and/or ruxolitinib is permitted

Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary AML based on WHO 2016 classification (Arber et al 2016)

Patients who are candidates for myeloablative or intensive chemotherapy treatment or who do not provide consent for this treatment

History of organ transplant or allogenic hematopoietic stem cell transplant

Trial design

Treatments tested in this trial

  • Axatilimab
  • Azacitidine
  • Biospecimen Collection
  • Bone Marrow Aspiration and Biopsy
  • Survey Administration

Treatment groups

52 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Uma Borate

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Incyte Corporation

Collaborator

Source ClinicalTrials.gov