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New hope for elderly leukemia patients: experimental combo trial launches

NCT ID NCT06389292

Disease control Sponsor: Ascentage Pharma Group Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This global phase 3 trial tests whether adding the experimental drug lisaftoclax to standard azacitidine helps older adults with newly diagnosed acute myeloid leukemia (AML) live longer. About 486 participants who cannot have intensive chemotherapy will receive either the combo or a placebo plus azacitidine. The main goal is overall survival, with secondary measures of response rates and safety.

What this could mean

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

Active substance
Lisaftoclax (APG-2575) combined with azacitidine
What this could lead to
If successful, this combination could offer a new treatment option that extends survival for elderly AML patients who cannot tolerate standard chemotherapy.
What could go wrong
This is a phase 3 trial, but the drug is still experimental. It may not improve survival or could cause side effects like low blood counts or infections.

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 486 people

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

Started

Jun 2024

Expected to finish

Mar 2029

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 must have newly diagnosed AML that meets the criteria for acute myeloid leukemia (AML) and ineligible for standard chemotherapy. 2. Life expectancy of ≥3 months. 3. Be able to accept oral administration. 4. Patients aged ≥70 years with ECOG score of 0-2, or those aged≥18 years and \<70 years with ECOG score of 0-3. 5. Adequate kidney function. 6. White blood cell ≤ 30×10\^9/L. 7. Adequate liver function. 8. Men, women with childbearing potential, and their partners voluntarily use contraception that researchers consider effective. 9. Be able to understand and voluntarily sign written informed consent. 10. Patients must be willing and able to complete study procedures and follow-up examinations. Exclusion Criteria: 1. The patient was diagnosed with acute promyelocytic leukemia or AML BCR-ABL1 positive. 2. Active leukemic infiltration of the central nervous system. 3. Active infection that is uncontrolled and requires systemic treatment. 4. Use of strong inducers of CYP3A4 within 7 days prior to the first dose of the investigational drug, and/or use of moderate to strong inhibitors of CYP3A4 within 7 days or 3-5 half-lives (whichever is longer) prior to the first dose of the investigational drug. 5. Previous treatment for hematologic disorders. 6. Patients who has a cardiovascular disability status of New York Heart Association Class \> 2. 7. Patients have malabsorption syndrome or other conditions that cannot be administered through the gastrointestinal tract or affect drug absorption. 8. Patients had a history of other malignancies prior to study initiation. 9. Any other circumstances or conditions, at the discretion of the investigator, make the patient unsuitable to participate in the study.

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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.

Acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 2 countries. 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

  • Botkin Moscow Multidisciplinary Research and Clinical Center

    RECRUITING

    Moscow, 125284, Russia

  • Hematology Hospital of the Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Leningrad Regional Clinical Hospital

    RECRUITING

    Saint Petersburg, 194291, Russia

  • Moscow Multidisciplinary Clinical Center "Kommunarka"

    RECRUITING

    Moscow, 108814, Russia

  • Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency

    RECRUITING

    Saint Petersburg, 191024, Russia

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

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