A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia

Summary

This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.

Eligibility

Inclusion Criteria:

1\. Patients meeting the World Health Organization (WHO) 2016 diagnostic criteria for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy:

1. Age ≥65 years, or
2. Age \>18 years and ineligible for standard-dose chemotherapy, defined by ≥1 of the following:

ECOG performance status 2 or 3；History of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤50% DLCO ≤65% or FEV1 ≤65%Creatinine clearance ≥30 mL/min but ≤45 mL/min (Cockcroft-Gault)、Any other condition deemed incompatible with standard chemotherapy (requires PI approval) 2. No prior AML therapy, except:Hydroxyurea. 3. ECOG performance status ≤3 4. Laboratory requirements: WBC≤3×10\*9/L、AST/ALT/ALP ≤3×ULN (except: due to leukemic involvement)、Total bilirubin ≤1.5×ULN、Serum creatinine clearance ≥30 mL/min (measured or calculated) 5. Life expectancy ≥3 months 6. Contraception requirements: Negative pregnancy test for women of childbearing potential；Agreement to use effective contraception during treatment and for 6 months after therapy

Exclusion Criteria:

1. AML with BCR::ABL1 fusion、Acute promyelocytic leukemia (APL).
2. Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN).
3. Use of strong/moderate CYP3A4 inducers within 3 days prior to treatment initiation.
4. Hypersensitivity to any study drugs.
5. Active malignancy in other organs (requiring treatment).
6. Active cardiac disease, defined as ≥1 of the following:Myocardial infarction within 6 months before enrollment；History of symptomatic arrhythmia requiring medication；Uncontrolled/symptomatic congestive heart failure (NYHA Class \>2)
7. Active infections, including:Untreated tuberculosis or any aspergillosis.
8. Known HIV, active hepatitis B (HBV), or hepatitis C (HCV).
9. Central nervous system (CNS) leukemia at baseline.
10. Conditions limiting oral drug absorption (e.g., malabsorption syndrome).
11. Medical history of:Epilepsy requiring medication、Dementia or psychiatric disorders impairing protocol compliance.
12. Investigator's discretion for ineligibility.

Conditions2

Interventions3

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