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New drug combo aims to boost survival in aggressive leukemia

NCT ID NCT07651163

Disease control Sponsor: First Affiliated Hospital of Zhejiang 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests three different chemotherapy regimens in 450 young adults (ages 15-65) with intermediate- or high-risk acute myeloid leukemia (AML). All regimens include the experimental drug lisaftoclax plus standard chemotherapies. The main goal is to see which combination leads to the highest 2-year survival rate. Participants are randomly assigned to one of three treatment groups.

What this could mean

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

Active substance
Lisaftoclax combined with standard chemotherapy drugs (daunorubicin, cytarabine, homoharringtonine, aclarubicin)
What this could lead to
If successful, this could point toward a more effective chemotherapy regimen for young adults with aggressive AML, potentially improving long-term survival.
What could go wrong
This is an early-to-mid-stage trial with 450 participants, so results may not apply to all patients. Chemotherapy side effects like infection and organ damage are significant risks.

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 450 people

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

Started

Mar 2026

Expected to finish

Dec 2029

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

15 to 65 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. Newly diagnosed acute myeloid leukemia (AML) confirmed according to the World Health Organization (WHO) classification; 2. Classified as intermediate- or adverse-risk AML based on the European LeukemiaNet (ELN) 2022 genetic risk stratification (see Appendix Table 1); 3. Age 15-65 years; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 5. Adequate hepatic and renal function: total bilirubin ≤2 mg/dL (35 μmol/L); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2× the upper limit of normal; serum creatinine ≤177 μmol/L; 6. Normal cardiac function, defined as left ventricular ejection fraction (LVEF) \>50%; 7. Life expectancy ≥3 months; 8. Signed written informed consent by the patient or their legally authorized representative prior to study enrollment. Exclusion Criteria: 1. Acute promyelocytic leukemia; 2. Central nervous system involvement by leukemia; 3. History of other malignancies within the past 5 years; 4. Positive for human immunodeficiency virus (HIV); 5. Presence of any other serious medical condition that may limit study participation, including advanced infections, uncontrolled diabetes mellitus, severe cardiac insufficiency, or angina; 6. Ineligible for intensive chemotherapy due to poor general condition; 7. Pregnant or breastfeeding women; 8. Inability to understand or comply with the study protocol; 9. Inability to take oral medication or presence of malabsorption syndrome; 10. Prior treatment with B-cell lymphoma 2 (BCL-2) inhibitors or hypomethylating agents, or current participation in any other investigational drug study; 11. Inability or unwillingness to provide written informed consent.

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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 (AML) Lisaftoclax

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

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang, 310000, China

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