OncoMatch/Clinical Trials/NCT06816134
Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia
Is NCT06816134 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including TmBU conditioning Regimen and mBUCY conditioning regimen for acute myeloid leukemia.
Treatment: TmBU conditioning Regimen · mBUCY conditioning regimen — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Disease stage
Required: Stage RELAPSED, PRIMARY REFRACTORY, HIGH-RISK AT DIAGNOSIS, MRD POSITIVE BEFORE TRANSPLANTATION
Relapsed/primary refractory ... or genetic high-risk group AML at diagnosis ... High-risk at diagnosis ... or MRD positive before transplantation B-ALL
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Kidney function
creatinine clearance ≥ 50ml/min
Liver function
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
Cardiac function
cardiac nyha grade ≤ 2, left ventricular ejection fraction ≥55%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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