MAX-40279 with Venetoclax and Azacitidine for unfit newly diagnosed AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, phase 2 trial with dose-escalation and expansion for unfit, newly diagnosed AML patients. Participants receive MAX-40279 at three oral dose levels in combination with venetoclax and azacitidine in 28-day cycles, with 28 days to observe dose-limiting toxicities after starting treatment. Evaluable patients who complete at least one cycle are included in preliminary efficacy analyses. The study aims to identify a tolerable dose and explore preliminary anti-leukemic activity in a population not candidates for intensive chemotherapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Jianxiang Wang, MD — Institute of Institute of Hematology & Blood Diseases Hospital
• Study coordinator: Jing Wang
• Email: jwang@maxinovel.com
• Phone: 8621-61009600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.