An interventional study of Chemotherapy-based Conditioning Regimen and TBI-based conditioning in Acute Lymphoblastic Leukemia and Hematopoietic Stem Cell Transplantation, sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
Adult ALL patients achieving second complete remission (CR2) represent a high-risk population for relapse after allo-HSCT. Allo-HSCT is the standard curative therapy, yet optimal preparative conditioning remains controversial. Most published evidence focuses on CR1 ALL patients; prospective head-to-head comparison between chemotherapy-only and TBI-based conditioning specifically for adult CR2 ALL is scarce and mainly relies on retrospective cohorts. While TBI-based conditioning provides favorable anti-leukemia effect, it carries substantial acute and late toxicities. Chemotherapy-only conditioning may reduce radiation-related toxicities but raises concern for higher relapse risk. This multicenter randomized phase III non-inferiority trial aims to provide prospective evidence to guide conditioning-regimen selection for adult ALL-CR2 patients undergoing allo-HSCT.
Eligible subjects are randomly assigned 1:1 via central stratified block randomization (variable block sizes:4,6,8). Investigators and participants are not blinded to treatment assignment; outcome assessment and statistical analysis are performed in a blinded fashion.
Experimental Arm (Busulfan-based chemotherapy-only conditioning): Busulfan 0.8 mg/kg q.i.d. day -8 to -6; cyclophosphamide 1.8 g/m²/day day -5, -4; semustine 250 mg/m² day -3. For haploidentical transplant recipients: rabbit-ATG 2.5 mg/kg/day day -5 to -2.
Active Comparator Arm (TBI-based conditioning): Total-body irradiation 770 cGy on day -6; cyclophosphamide 1.8 g/m²/day day -5, -4; semustine 250 mg/m² day -3. For haploidentical transplant recipients: rabbit-ATG 2.5 mg/kg/day day -5 to -2.
Grafts consist of G-CSF-mobilized bone marrow plus peripheral-blood stem cells. Uniform post-transplant GVHD prophylaxis includes cyclosporine-A, mycophenolate mofetil, and short-course methotrexate.
Planned follow-up time-points: +1, +2, +3, +4.5, +6, +9, +12, +18, +24, +36, +48, +60 months post-transplant. Assessments include bone-marrow morphology, multiparameter flow MRD, molecular MRD (fusion gene / Ig-TCR / NGS), chimerism analysis, complete blood count, biochemistry, virology screening, and GVHD evaluation per NIH consensus criteria.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 180 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Significant organ dysfunction:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
intervention： Drug: Busulfan: 0.8 mg/kg intravenous, four times daily, day -8 to day -6 Drug: Cyclophosphamide: 1.8 g/m²/day intravenous, day -5, day -4 Drug: Semustine: 250 mg/m² oral, day -3 Drug: Rabbit anti-thymocyte globulin (ATG): 2.5 mg/kg/day intravenous day -5 to -2 (only for haploidentical transplant recipients) All subjects receive identical post-transplant GVHD-prophylaxis: cyclosporine-A, mycophenolate mofetil, short-course methotrexate; standard supportive care.
Drug: Chemotherapy-based Conditioning Regimen
intervention Radiation: Total-Body Irradiation (TBI): 770 cGy administered on day -6 Drug: Cyclophosphamide: 1.8 g/m²/day intravenous, day -5, day -4 Drug: Semustine: 250 mg/m² oral, day -3 Drug: Rabbit anti-thymocyte globulin (ATG): 2.5 mg/kg/day intravenous day -5 to -2 (only for haploidentical transplant recipients) All subjects receive identical post-transplant GVHD-prophylaxis: cyclosporine-A, mycophenolate mofetil, short-course methotrexate; standard supportive care.
Radiation: TBI-based conditioning
Experimental Arm (Chemotherapy-based conditioning): Busulfan 0.8 mg/kg q.i.d. day -8 to -6; cyclophosphamide 1.8 g/m²/day day -5, -4; semustine 250 mg/m² day -3. For haploidentical transplant recipients: rabbit-ATG 2.5 mg/kg/day day -5 to -2.
Active Comparator Arm (TBI-based conditioning): Total-body irradiation 770 cGy on day -6; cyclophosphamide 1.8 g/m²/day day -5, -4; semustine 250 mg/m² day -3. For haploidentical transplant recipients: rabbit-ATG 2.5 mg/kg/day day -5 to -2.
1-Year Leukemia-Free Survival (LFS)
Time from stem-cell infusion to leukemia relapse or death from any cause, whichever occurs first.
Time frame: 12 months post-hematopoietic stem-cell infusion]
1-Year Treatment-Related Mortality (TRM)
Cumulative incidence of non-relapse-related death after transplantation (competing risk: leukemia relapse).
Time frame: 12 months post-transplantation
Cumulative Incidence of Relapse (CIR)
Cumulative probability of hematologic or molecular leukemia relapse with death as competing risk event.
Time frame: 1-year, 2-year, 3-year post-transplantation
Cumulative Incidence of Acute and Chronic Graft-Versus-Host Disease (GVHD)
Cumulative incidence of grade II-IV, grade III-IV acute GVHD (100-day landmark); cumulative incidence of mild/moderate/severe chronic GVHD within 3 years, graded according to NIH GVHD consensus criteria.
Time frame: Day 100, 1-year, 3-year post-transplantation
Overall Survival (OS)
Time from stem-cell infusion until death from any cause.
Time frame: 1-year, 2-year, 3-year post-transplantation
Conditioning-related organ toxicities
Incidence of grade 1-4 cardiac, hepatic, renal, gastrointestinal and mucosal toxicities from conditioning initiation up to day +30 post-transplantation, graded by WHO organ-toxicity scale.
Time frame: Conditioning start up to post-transplant day +30
Hematopoietic engraftment
Neutrophil engraftment: sustained ANC ≥ 0.5 × 10⁹/L for three consecutive days; platelet engraftment: sustained PLT ≥ 20 × 10⁹/L without transfusion support for seven consecutive days.
Time frame: Day 30 and Day 90 post-transplantation
Molecular/Flow-MRD status post-transplant
MRD positive defined as flow cytometry ≥ 0.01 %; or detectable quantifiable fusion-gene / Ig-TCR / NGS clonal signal above assay sensitivity threshold at serial follow-up time-points.
Time frame: +1, +2, +3, +6, +12 months post-transplantation
Plan to share: No
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