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New drug aims to stop deadly complication in leukemia therapy

NCT ID NCT07597941

Prevention Sponsor: The Affiliated People's Hospital of Ningbo University 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Updated 2 times

Summary

This study tests whether the drug Lisaftoclax can prevent differentiation syndrome (DS), a severe and sometimes life-threatening side effect, in people with acute promyelocytic leukemia (APL) who are receiving standard treatment. About 60 participants aged 16 and older will take Lisaftoclax alongside their usual therapy. The goal is to see if this approach lowers the rate of DS and improves safety.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 20 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

16 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 aged ≥ 16 years old. * 2\. Confirmed diagnosis of acute promyelocytic leukemia (APL) by morphology, flow cytometry, and cytogenetics/molecular testing. * 3\. ECOG performance status 0-2. * 4\. Adequate organ function: * Serum creatinine ≤ 1.5 × ULN * Total bilirubin ≤ 2 × ULN * AST/ALT ≤ 3 × ULN * 5\. Able to understand and sign the informed consent form. Exclusion Criteria: * 1\. Concurrent participation in another interventional clinical trial. * 2\. History of other malignancies within the past 5 years (except cured basal cell carcinoma or in situ cervical cancer). * 3\. Severe uncontrolled infection or other serious underlying diseases that may interfere with study treatment or follow-up. * 4\. Known hypersensitivity to lisaftoclax, ATRA, ATO, or any components of the study regimen. * 5\. Pregnant or breastfeeding women.

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Conditions

The condition(s) this trial relates to.

acute promyelocytic leukemia

As listed by the trial registrant

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

Acute promyelocytic leukemia (APL)

How to take part

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

  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

    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.

More trials for these conditions

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