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New hope for elderly leukemia patients: study tests gentler chemo combo

NCT ID NCT07132684

Disease control Sponsor: Institute of Hematology & Blood Diseases Hospital, China Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a newer, targeted drug combination (venetoclax plus azacitidine) works better than standard intensive chemotherapy for adults aged 55 to 75 with acute myeloid leukemia (AML). About 240 participants will be randomly assigned to one of the two treatments. The main goal is to see which approach helps people live longer, with fewer side effects.

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 240 people

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

Started

Aug 2025

Expected to finish

Aug 2028

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

55 to 75 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: * Diagnosis of AML according to WHO (2022) or ICC criteria. * Age ≥55 and ≤75 years. * ECOG performance status score of 0-2. * Adequate organ function: * Total bilirubin ≤1.5× upper limit of normal (ULN) * AST and ALT ≤2.5× ULN * Serum creatinine \<2× ULN * Cardiac enzymes \<2× ULN * Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative. Exclusion Criteria: * Acute promyelocytic leukemia with PML-RARA fusion gene. * AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes. * AML with BCR-ABL fusion gene. * Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed). * Concurrent other malignancies requiring treatment. * Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal). * Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis). * Other conditions deemed unsuitable by the investigator.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AML, adult

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

  • Blood Diseases Hospital

    RECRUITING

    Tianjin, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.