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Can a new drug trio overcome venetoclax resistance in leukemia?

NCT ID NCT07813390

Disease control Sponsor: Guangdong Second Provincial General Hospital Source: ClinicalTrials.gov ↗

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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether a combination of homoharringtonine, lisaftoclax, and azacitidine can help adults with acute myeloid leukemia (AML) whose disease stopped responding to venetoclax-based treatment. The trial plans to enroll 73 participants and give them the three drugs in 28-day cycles. The main goal is to see how many participants respond after two cycles, with secondary measures including remission rates, residual disease, survival, and side effects.

What this could mean

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

Active substance
a three-drug combination of homoharringtonine, lisaftoclax, and azacitidine
What this could lead to
If it works, this could offer a new option for AML that has stopped responding to venetoclax, a situation where few treatments help.
What could go wrong
This is a single-arm phase 2 trial with no comparison group, so any benefit is hard to separate from chance or supportive care. The combination may not work, and it can cause serious 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 2

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

Participants

About 73 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

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

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. Diagnosis of acute myeloid leukemia according to the World Health Organization classification. 2. Age 18 years or older. 3. Failure after venetoclax exposure, defined as either no response after at least 2 consecutive cycles of a venetoclax-containing regimen or disease relapse during continued, protocol-compliant treatment with a venetoclax-containing regimen after a prior response. 4. Creatinine clearance of at least 30 mL/min. 5. Alanine aminotransferase less than 5 times the upper limit of normal and bilirubin less than 3 times the upper limit of normal. 6. Life expectancy of at least 3 months. 7. Able to receive oral lisaftoclax. 8. Able to understand and comply with protocol procedures and willing to provide written informed consent. Exclusion Criteria: 1. Acute promyelocytic leukemia. 2. Acute myeloid leukemia with central nervous system involvement. 3. Acute myeloid leukemia with FLT3, IDH1/2, or NPM1 mutations or MLL rearrangement for which could be treated with a corresponding targeted inhibitor. 4. Other clinically significant uncontrolled conditions, including but not limited to an uncontrolled or active systemic viral, bacterial, or fungal infection; chronic hepatitis B virus or hepatitis C virus infection requiring treatment; or a concurrent second malignancy requiring active treatment. 5. Known hypersensitivity to any study drug. 6. Active human immunodeficiency virus infection. 7. Pregnant or breastfeeding. 8. Any condition that, in the investigator's opinion, makes the patient unsuitable for enrollment.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia Neoplasm, Residual

As listed by the trial registrant

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

Acute myeloid leukemia (AML)

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong, 510317, China

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