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NCT06816134RecruitingPhase 2

Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia

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

Source: ClinicalTrials.gov · Last updated 23 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
48 (estimated)
First submitted
4 Feb 2025
Start date
30 Jan 2025
Primary completion date
30 Jan 2028
Lead sponsor
The First Affiliated Hospital of Soochow University
NCT number
NCT06816134

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 48
  • From 30 Jan 2025 to the primary completion date, 30 Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 15 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Soochow University
Coordinator of this site? Confirm its status		SuzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.