Actively Recruiting
Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2026-04-23
48
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of AML or ALL with indications for allo-HSCT including relapsed/primary refractory or genetic high-risk AML, high-risk or MRD positive B-ALL before transplantation, confirmed T-ALL, or history of CNS leukemia or extramedullary disease
- Age 15 to 65 years old
- HCT-CI score less than 2 and ECOG performance status 0 to 2
- Adequate organ function: cardiac NYHA grade 2 or less with at least 55% ejection fraction, creatinine clearance 50 ml/min or greater, liver enzymes (ALT and AST) less than or equal to 2.5 times normal, total bilirubin less than or equal to 1.5 times normal, and oxygen saturation above 92% without oxygen
- Expected survival time of 3 months or more
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Presence of other malignant tumors treated within past 3 years
- Previous or current central nervous system diseases such as epilepsy, seizures, paralysis, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or CNS-related autoimmune diseases
- HIV, syphilis infection, or uncontrolled active infections including bacterial, fungal, or viral
- Active hepatitis B or C infection
- Cardiac angioplasty or stent implantation within the past 12 months or medical treatment needed for coronary heart disease
- Primary immunodeficiency or active autoimmune disease
- History of severe immediate allergic reactions to study drugs
- Receipt of live vaccine within 6 weeks prior to screening
- Pregnant or breastfeeding females and those unwilling to use contraception
- Inability to comply with study requirements due to psychiatric illness or other conditions
- Investigator's judgment of unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
S
Sheng-Li Xue, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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