RecruitingPhase 2

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

China48 participantsStarted 2025-01-30

Plain-language summary

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.

Who can participate

Age range15 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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

What they're measuring

Cumulative incidence of relapse（CIR）

Timeframe: 2 years

Trial details

NCT IDNCT06816134

SponsorThe First Affiliated Hospital of Soochow University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-30

Contact for this trial

Sheng-Li Xue, M.D.

008651267781139 slxue@suda.edu.cn

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials