Can a Triple-Drug combo tame acute myeloid leukemia in frail patients?
NCT ID NCT07743112
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding an experimental drug called MAX-40279 to the standard combination of venetoclax and azacitidine can help treat newly diagnosed acute myeloid leukemia (AML) in people who are not healthy enough for intensive chemotherapy. The study includes adults aged 65 or older, or younger adults with conditions like heart or lung problems that make standard chemo too risky. Researchers are looking at safety, the right dose, and how well the combination works at achieving remission.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MAX-40279 combined with venetoclax and azacitidine
- What this could lead to
- If this combination works, it could offer a new, gentler treatment option for older or frail adults with acute myeloid leukemia who cannot tolerate intensive chemotherapy.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the benefits are uncertain. The drug combination may cause side effects, and it is not yet known if it will improve remission or survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 43 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)
RECRUITINGTianjin, China
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