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Can a Triple-Drug combo tame acute myeloid leukemia in frail patients?

NCT ID NCT07743112

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 43 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Institute of Institute of Hematology & Blood Diseases Hospital ( Chinese Academy of Medical Sciences)

    RECRUITING

    Tianjin, China

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