MAX-40279 added to venetoclax and azacitidine for newly diagnosed acute myeloid leukemia
Tests MAX-40279 with venetoclax and azacitidine in adults newly diagnosed with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Where in China
- Institute of Institute of Hematology & Blood Diseases Hospital (Chinese Academy of Medical Sciences)Tianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maxinovel Pty., Ltd.
- Trial code
- NCT07743112
- Record updated
- 3 August 2026
- Original description
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.Read full original descriptionShow less
A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.
Inclusion: Patients meeting the World Health Organization (WHO) 2016 diagnostic criteria for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy:; Age ≥65 years, or; 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: Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN); Use of strong/moderate CYP3A4 inducers within 3 days prior to treatment initiation; 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); Hypersensitivity to any study drugs; Active malignancy in other organs (requiring treatment); Active infections, including:Untreated tuberculosis or any aspergillosis; Known HIV, active hepatitis B (HBV), or hepatitis C (HCV); Conditions limiting oral drug absorption (e.g., malabsorption syndrome); Medical history of:Epilepsy requiring medication、Dementia or psychiatric disorders impairing protocol compliance; AML with BCR::ABL1 fusion、Acute promyelocytic leukemia (APL); Central nervous system (CNS) leukemia at baseline; Investigator's discretion for ineligibility.