OncoMatch/Clinical Trials/NCT06523556
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
Is NCT06523556 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Axatilimab and Azacitidine for atypical chronic myeloid leukemia.
Treatment: Axatilimab · Azacitidine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Acute Myeloid Leukemia
Myeloproliferative Neoplasm
Biomarker criteria
Required: SF3B1 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine or INQOVI (oral decitabine) (lenalidomide, decitabine, azacitidine, INQOVI)
Exception: patients who had up to 2 cycles of hypomethylating agents [HMAs] can be included; previous treatment with hydroxyurea and/or ruxolitinib is permitted
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
Lab requirements
Kidney function
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m^2 (MDRD formula, by local laboratory)
Liver function
AST and ALT ≤ 3 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)
AST and ALT ≤ 3 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome); Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m^2 (MDRD formula, by local laboratory)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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