NCT07743112 A Phase 2 Study of MAX-40279 Combined With Venetoclax and Azacitidine in Unfit Newly Diagnosed Acute Myeloid Leukemia
| NCT ID | NCT07743112 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Maxinovel Pty., Ltd. |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 43 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 43 participants in total. It began in 2025-09-05 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, multicenter, phase Ⅱ study consisting of dose escalation and ex-pansion stages in unfit newly diagnosed AML.
Eligibility Criteria
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.
Contact & Investigator
Jianxiang Wang, MD
PRINCIPAL INVESTIGATOR
Institute of Institute of Hematology & Blood Diseases Hospital
Frequently Asked Questions
Who can join the NCT07743112 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07743112 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07743112 currently recruiting?
Yes, NCT07743112 is actively recruiting participants. Contact the research team at jwang@maxinovel.com for enrollment information.
Where is the NCT07743112 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07743112 clinical trial?
NCT07743112 is sponsored by Maxinovel Pty., Ltd.. The principal investigator is Jianxiang Wang, MD at Institute of Institute of Hematology & Blood Diseases Hospital. The trial plans to enroll 43 participants.
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