Compares two preparation treatments before stem cell transplant for leukemia
Compares two conditioning regimens before transplant in people with high-risk or relapsed leukemia.
Plain-language title generated from the registry record
Registry title: Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia
Key facts
- Where
- Suzhou, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 15 to 65 with high-risk, relapsed or treatment-resistant acute leukemia (AML or ALL) who are going to have a donor stem cell transplant. It compares two conditioning regimens given before the transplant.
- Age
- 15 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that is high-risk, relapsed or does not respond to treatment, with a reason for a donor stem cell transplant (allo-HSCT). Examples: B-ALL with positive MRD before transplant, T-ALL, or a history of central nervous system leukemia or extramedullary disease.
Main reasons for not taking part
- Another cancer treated within the past 3 years
- Other brain or nervous system disease, such as epilepsy, stroke or dementia
- HIV or syphilis infection, active hepatitis B or C, or other uncontrolled infection
- Recent heart stent or angioplasty (within 12 months), or coronary heart disease needing treatment
- Pregnant or breastfeeding women, or people of childbearing potential unwilling to use contraception
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 15 and 65 years old?
Source: NCT06816134, who can take part
Where in China
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The First Affiliated Hospital of Soochow University
- Trial code
- NCT06816134
- Record updated
- 23 April 2026
- Original description
This project is a prospective, single-center, randomized controlled clinical study. The subjects were high-risk or relapsed/refractory AML or ALL patients aged ≤ 65 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The TmBU scheme or modified Bu/Cy (mBuCy) scheme was used for pretreatment in allo-HSCT. The primary endpoint of the study was the 2-year cumulative incidence of relapse (CIR) after allo-HSCT, and the secondary endpoints were 2-year overall survival rate (OS), progressing-free survival rate (PFS), non-relapse mortality rate (NRM), graft-versus-host disease (GVHD)-free relapse-free survival (GRFS) rate.Read full original descriptionShow less
A Prospective, Randomized Controlled Clinical Study on the Efficacy and Safety of the TmBU Regimen Versus mBUCY Regimen for Conditioning Before Allo-HSCT in High-risk or Relapsed/Refractory Acute Leukemia
This project is a prospective, single-center, randomized controlled clinical study. The subjects were high-risk or relapsed/refractory AML or ALL patients aged ≤ 65 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The TmBU scheme or modified Bu/Cy (mBuCy) scheme was used for pretreatment in allo-HSCT. The primary endpoint of the study was the 2-year cumulative incidence of relapse (CIR) after allo-HSCT, and the secondary endpoints were 2-year overall survival rate (OS), progressing-free survival rate (PFS), non-relapse mortality rate (NRM), graft-versus-host disease (GVHD)-free relapse-free survival (GRFS) rate.
Inclusion: Confirmed diagnosis of AML or ALL according to WHO 2022 guideline criteria, with indications for allo-HSCT list below:; Relapsed/primary refractory (definitions refer to NCCN 2025) or genetic high-risk group AML at diagnosis (risk stratification refers to ELN 2022); High-risk at diagnosis (risk stratification refers to ELN 2022) or MRD positive before transplantation B-ALL; Confirmed diagnosis of T-ALL; 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:; Cardiac NYHA grade ≤ 2, left ventricular ejection fraction ≥55%; Creatinine clearance ≥ 50ml/min; 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; Oxygen saturation > 92% without oxygen; Expected survival time ≥ 3 months; Ability to understand and voluntarily sign the informed consent form.
Exclusion: 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; 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; 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; HIV/Syphilis infection or uncontrolled active other infections (bacteria or fungus or virus is included); With active hepatitis B or hepatitis C infection; With primary immunodeficiency or active autoimmune disease; Inability to cooperate with the requirements of study, treatment and monitoring due to psychiatric illness or other conditions; Pregnant, lactating females and patients of childbearing potential who are unwilling to use contraception; Patients not suitable for the study according to the investigator's assessment.