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Could a shorter treatment be just as good for AML in the elderly?

NCT ID NCT07407660

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving a shorter course of the drug venetoclax (combined with azacitidine) works as well as the standard longer course for older or frail patients with acute myeloid leukemia (AML). The researchers will check bone marrow on day 14 to decide if the drug can be stopped early. The trial plans to enroll 250 participants and compare how many achieve remission within two cycles.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
venetoclax and azacitidine
What this could lead to
If successful, this could lead to a shorter, less toxic treatment option for elderly or frail patients with acute myeloid leukemia, potentially reducing side effects while maintaining effectiveness.
What could go wrong
This is a phase 3 trial, but it has not yet started recruiting. The shortened course may not be as effective as the standard regimen, and there is a risk of disease progression or relapse.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

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 with newly diagnosed acute myeloid leukemia who meet the WHO 2022 criteria. 2. Meeting one of the following conditions: 1. Aged ≥ 60 years; 2. aged ≥ 18 years and \< 60 years, with one or more of the following comorbidities that render the subject unsuitable for intensive induction therapy: * Complicated with congestive heart failure, or left ventricular ejection fraction ≤ 50%, or a history of chronic stable angina pectoris; * A history of pulmonary disease, with carbon monoxide diffusing capacity of the lung (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%; * Creatinine clearance rate \< 45 mL/min (calculated by the \*\*Cockcroft-Gault formula\*\*); * Total bilirubin \> 1.5 × upper limit of normal; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score ≥ 2; * Any other comorbidities judged by the investigator to contraindicate intensive induction therapy. 3. Received induction therapy with the azacitidine plus venetoclax regimen (azacitidine for injection: 75 mg/m² subcutaneously on Days 1-7; venetoclax tablets: 100 mg on Day 1, 200 mg on Day 2, and 400 mg once daily starting on Day 3) for 12-14 days. Dose adjustment of venetoclax shall be performed if combined with strong or moderate CYP3A/P-gp inhibitors. 4. Completed risk stratification assessment per the ELN 2022 criteria. 5. Signed the informed consent form. Exclusion Criteria: 1. Diagnosis of acute promyelocytic leukemia, AML with t(8;21)(q22;q22.1)/ RUNX1::RUNX1T1 translocation, or blast crisis of chronic myeloid leukemia (CML). 2. Prior treatment with venetoclax before the diagnosis of acute myeloid leukemia. 3. A history of allogeneic hematopoietic stem cell transplantation. 4. Severe hepatic or renal impairment, defined by the presence of any of the following abnormalities: aspartate aminotransferase (AST) \> 2.5 × ULN; alanine aminotransferase (ALT) \> 2.5 × ULN; creatinine clearance rate \< 30 mL/min (calculated by the Cockcroft-Gault formula); or total bilirubin \> 3 × ULN. 5. Presence of acute active infection requiring intravenous systemic therapy. 6. Presence of active malignant tumors requiring antineoplastic treatment. 7. Presence of active autoimmune diseases requiring treatment with prednisone ≥ 15 mg/day or equivalent doses of other glucocorticoids, or any other immunosuppressive agents. 8. Inability to swallow tablets, or presence of diseases significantly impairing gastrointestinal function (e.g., malabsorption syndrome, gastrectomy or enterectomy, bariatric surgery, symptomatic inflammatory bowel disease, or partial/complete intestinal obstruction). 9. Pregnant or lactating female subjects. 10. Subjects judged by the investigator to be unable to comply with the protocol due to uncontrollable medical, psychological, familial, social, or geographic conditions; or those who are unwilling or unable to follow the required procedures of the protocol.

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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

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  1. 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 ↗

  2. A doctor treating you

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