New drug cocktail aims to stop leukemia return after transplant
NCT ID NCT07686965
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 191 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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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.
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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.
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Other studies related to the condition(s) this trial covers.
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- Can a new drug combo outperform standard care for a tough blood cancer?
- Can donor immune cells fight leukemia relapse after transplant?