NCT07919470Not yet recruiting
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT
Busulfan Based Versus Total Body Irradiation Based for Adults Acute B Lymphoblastic Leukemia in CR2: An Multicenter, Non-Inferiority Study
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 31 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- Peking University People's Hospital
- NCT number
- NCT07919470
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 Nov 2026 to the primary completion date, 1 Nov 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another investigational drug trial within past 3 months.
Other illness
- 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.
Lab values
- 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).
Other
- Diagnosis of acute biphenotypic leukemia.
Who the study is looking for
- 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.
Age in the registry: 14 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital, Beijing Lu Daopei Hematology Hospital, Hebei Yanda Lu Daopei Hospital, Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.