OncoMatch

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 (Jun 2026). This Phase 2 trial studies multiple treatments including TmBU conditioning Regimen and mBUCY conditioning regimen for acute myeloid leukemia.

Phase 2RecruitingThe First Affiliated Hospital of Soochow UniversityNCT06816134Data as of Jun 2026Location: China

Treatment: TmBU conditioning Regimen · mBUCY conditioning regimenThis 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 qualify

Extracted eligibility criteria

Treatments studied

Other

TmBU conditioning RegimenmBUCY conditioning regimen

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)

Demographics

Ages 15–65

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.

Frequently asked questions

Is NCT06816134 currently recruiting?

Yes, this trial is currently recruiting patients.

What disease stage is eligible?

Stage RELAPSED or PRIMARY REFRACTORY or HIGH-RISK AT DIAGNOSIS or MRD POSITIVE BEFORE TRANSPLANTATION is required.

Is there an age limit?

Yes. Patients must be 65 years or younger and at least 15 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify