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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed acute myeloid leukemia (AML) who cannot have intensive chemotherapy.
- Age
- Age 65 or older, or older than 18 and unable to have standard-dose chemotherapy.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML (WHO 2016 criteria) who are unfit for intensive chemotherapy. Reasons include ECOG performance status 2 or 3, heart failure, or weak lung or kidney function.
- Earlier treatment
- No earlier treatment for AML, except hydroxyurea.
Main reasons for not taking part
- AML with the BCR::ABL1 fusion, or acute promyelocytic leukemia (APL)
- Secondary AML, including after earlier cancer treatment, myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN)
- Known HIV, active hepatitis B or hepatitis C
- Leukemia in the central nervous system (CNS)
- Heart attack within 6 months, or uncontrolled or symptomatic heart failure
Read by machine on 9 November 2026.
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.