Busulfan Chemotherapy Versus Radiation Before Transplant in Adults With Leukemia
Compares busulfan chemotherapy with radiation before stem cell transplant in adults with leukemia.
Plain-language title generated from the registry record
Registry title: Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 65 years old?
Source: NCT07919470, who can take part
Where in China
- Peking University People's Hospital, Beijing Lu Daopei Hematology Hospital, Hebei Yanda Lu Daopei Hospital, Nanfang Hospital, Southern Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT07919470
- Record updated
- 5 November 2026
- Original description
This is an multicenter, non-inferiority randomized controlled trial. Adult patients (14-65 years) with acute lymphoblastic leukemia in second complete remission (CR2) scheduled for allogeneic hematopoietic stem-cell transplantation (allo-HSCT) will be randomized 1:1 to receive either busulfan-based chemotherapy-only conditioning (experimental arm) or total-body-irradiation (TBI)-based conditioning (active comparator arm). The primary objective is to test the non-inferiority of chemotherapy-based conditioning versus TBI-based conditioning regarding 1-year leukemia-free survival (LFS). Secondary endpoints include treatment-related mortality (TRM), cumulative incidence of relapse (CIR), graft-versus-host-disease (GVHD), and overall survival (OS). All patients receive uniform GVHD prophylaxis and post-transplant supportive care.Read full original descriptionShow less
Busulfan Based Versus Total Body Irradiation Based for Adults Acute B Lymphoblastic Leukemia in CR2: An Multicenter, Non-Inferiority Study
This is an multicenter, non-inferiority randomized controlled trial. Adult patients (14-65 years) with acute lymphoblastic leukemia in second complete remission (CR2) scheduled for allogeneic hematopoietic stem-cell transplantation (allo-HSCT) will be randomized 1:1 to receive either busulfan-based chemotherapy-only conditioning (experimental arm) or total-body-irradiation (TBI)-based conditioning (active comparator arm). The primary objective is to test the non-inferiority of chemotherapy-based conditioning versus TBI-based conditioning regarding 1-year leukemia-free survival (LFS). Secondary endpoints include treatment-related mortality (TRM), cumulative incidence of relapse (CIR), graft-versus-host-disease (GVHD), and overall survival (OS). All patients receive uniform GVHD prophylaxis and post-transplant supportive care.
Inclusion: Age ≥ 14 and ≤ 65 years (inclusive); Diagnosis of acute lymphoblastic leukemia according to NCCN diagnostic criteria; Confirmed second complete remission (CR2) before allogeneic hematopoietic stem-cell transplantation; Planned to undergo allo-HSCT; ECOG performance status < 3; Written informed consent obtained.
Exclusion: Participation in another investigational drug trial within past 3 months; Uncontrolled active infection at screening; Psychiatric disorders interfering with protocol compliance; History of other malignant neoplasms within 2 years prior to screening; Any condition judged by investigator rendering subject unsuitable for trial participation; Significant organ dysfunction:; Liver: ALT/AST > 3.0 × ULN and/or total bilirubin > 1.5 × ULN; severe cirrhosis, portal hypertension or active liver disease; Renal: eGFR < 60 mL/min/1.73 m² by CKD-EPI formula or serum creatinine > 1.5 × ULN; regular dialysis requirement; Cardiac: NYHA class III-IV heart failure; unstable angina / myocardial infarction / coronary revascularization within prior 6 months; LVEF < 50 %; clinically significant uncontrolled arrhythmia; Pulmonary: chronic lung disease requiring long-term oxygen therapy; resting SpO₂ < 92 % (room-air); Diagnosis of acute biphenotypic leukemia.