New drug cocktail aims to stop leukemia return after transplant

NCT ID NCT07686965

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial tests whether a combination of two drugs, lisaftoclax and azacitidine, can help prevent acute myeloid leukemia (AML) from coming back in patients who have already received a stem cell transplant and are at high risk of relapse. Participants are randomly assigned to receive the drug combo or standard observation. The study tracks how long they stay cancer-free and any 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
lisaftoclax plus azacitidine
What this could lead to
If successful, this maintenance therapy could reduce the chance of leukemia returning after a stem cell transplant and improve long-term survival for high-risk patients.
What could go wrong
This is a Phase 3 trial, but the combination may cause side effects like low blood counts or infections, and it is not yet proven to work better than observation alone.

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 191 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

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 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: Participants must meet all of the following criteria to be eligible for enrollment in this study: 1. Diagnosed with acute myeloid leukemia (AML), excluding acute promyelocytic leukemia, according to the WHO 2022 classification, and without FLT3-ITD or FLT3-TKD mutations. 2. Presence of at least one of the following high-risk features: 1\) Adverse-risk AML according to the ELN 2022 risk classification; 2) Refractory AML; 3) Relapsed AML; 4) Persistent measurable residual disease positivity prior to transplantation; 5) Secondary AML transformed from myelodysplastic syndrome or myeloproliferative neoplasm. 3\. Undergoing first allogeneic hematopoietic stem cell transplantation (allo-HSCT). 4\. Stable hematologic recovery, defined as: Absolute neutrophil count ≥ 1.0 × 10⁹/L without G-CSF support; and Platelet count ≥ 50 × 10⁹/L without platelet transfusion within 7 days prior to randomization. 5\. Age ≥18 years and ≤75 years. 6. Eastern Cooperative Oncology Group performance status of 0-2. 7. Ability to provide written informed consent before initiation of any study procedures. 8\. Written informed consent may be provided by the participant or an authorized immediate family member in accordance with local regulations. Exclusion Criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Evidence of disease relapse or impending relapse prior to randomization after transplantation, as determined by morphologic assessment or flow cytometry. 2. Active or uncontrolled acute graft-versus-host disease (aGVHD) requiring systemic immunosuppressive therapy. 3. Uncontrolled active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 7 days prior to enrollment. 4. Moderate or severe hepatic impairment, as defined by the Child-Pugh classification. 5. Severe renal impairment, defined as creatinine clearance \<30 mL/min (calculated using the Cockcroft-Gault formula) or requirement for dialysis. 6. Pregnancy, or unwillingness/inability to use adequate contraception during the study treatment period. 7. Psychiatric disorders or other medical conditions that, in the investigator's judgment, would interfere with compliance with study treatment, monitoring, or study procedures.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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