New chemo combo aims to cut leukemia relapse after transplant
NCT ID NCT06816134
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new chemotherapy combination (TmBU) works better than the standard one (mBUCY) before a stem cell transplant in people with high-risk or hard-to-treat acute leukemia. About 48 patients aged 65 or younger will be randomly assigned to one of the two regimens. The main goal is to see if the new combo lowers the chance of leukemia coming back within two years after transplant.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 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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15 to 65 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: * Confirmed diagnosis of AML or ALL according to WHO 2022 guideline criteria, with indications for allo-HSCT list below: 1. Relapsed/primary refractory (definitions refer to NCCN 2025) or genetic high-risk group AML at diagnosis (risk stratification refers to ELN 2022) 2. High-risk at diagnosis (risk stratification refers to ELN 2022) or MRD positive before transplantation B-ALL 3. Confirmed diagnosis of T-ALL 4. History of central nervous system leukemia (CNSL) or histopathologically confirmed extramedullary manifestation (EMD) during the course of the AML or ALL * Age 15-65 years old (≤ 65 years old) * HCT-CI score \< 2 points ECOG 0-2 points * Adequate organ function: 1. Cardiac NYHA grade ≤ 2, left ventricular ejection fraction ≥55% 2. Creatinine clearance ≥ 50ml/min 3. ALT and AST ≤ 2.5 times the upper limit of the normal range, and total bilirubin ≤ 1.5 times the upper limit of the normal range 4. Oxygen saturation \> 92% without oxygen * Expected survival time ≥ 3 months * Ability to understand and voluntarily sign the informed consent form Exclusion Criteria: * With other malignant tumors and have received any treatment for this tumor within the past 3 years * Previous or current other CNS disease (such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis) or any CNS-related autoimmune disease * HIV/Syphilis infection or uncontrolled active other infections (bacteria or fungus or virus is included) * With active hepatitis B or hepatitis C infection * Patients received cardiac angioplasty or stent implantation within 12 months before signing the informed consent form, or have symptoms requiring medical treatment for coronary heart disease * With primary immunodeficiency or active autoimmune disease * Previous history of severe immediate hypersensitivity reactions to any of the drugs to be used in this study * Received a live vaccine within 6 weeks prior to screening * Pregnant, lactating females and patients of childbearing potential who are unwilling to use contraception * Inability to cooperate with the requirements of study, treatment and monitoring due to psychiatric illness or other conditions * Patients not suitable for the study according to the investigator's assessment
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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 places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215006, China
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Other studies related to the condition(s) this trial covers.
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- Can a Chemo-Only prep beat radiation for childhood leukemia transplants?
- Can a targeted drug hit the mark in Hard-to-Treat blood cancers?
- Can a new drug pair beat standard chemotherapy for tough AML?