Acute Lymphoblastic LeukemiaNCT07919470
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT
A study testing Chemotherapy-based Conditioning Regimen and TBI-based conditioning in people with Acute Lymphoblastic Leukemia and Hematopoietic Stem Cell Transplantation, run by Peking University People's Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Chemotherapy-based Conditioning Regimen and TBI-based conditioning
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diagnosis of acute biphenotypic leukemia.
- Uncontrolled active infection at screening.
- 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.
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- Pulmonary: chronic lung disease requiring long-term oxygen therapy; resting SpO₂ < 92 % (room-air).
- Participation in another investigational drug trial within past 3 months.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital, Beijing Lu Daopei Hematology Hospital, Hebei Yanda Lu Daopei Hospital, Nanfang Hospital, Southern Medical University
Beijing
Xiaojun Huang, 8610-8832-6005, huangxiaojun@bjmu.edu.cn
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Chemotherapy-based Conditioning Regimen, TBI-based conditioning
- Keywords
- acute lymphoblastic leukemia, allogeneic hematopoietic stem cell transplantation, conditioning regimen, total-body irradiation, busulfan, second complete remission, non-inferiority trial
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy-based Conditioning RegimenDrug
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.
TBI-based conditioningRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy-only Conditioning Regimen | Experimental | 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. Receives: Drug: Chemotherapy-based Conditioning Regimen |
| TBI-based Conditioning Regimen | Active comparator | 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. Receives: Radiation: TBI-based conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Leukemia-Free Survival (LFS)
Time from stem-cell infusion to leukemia relapse or death from any cause, whichever occurs first.
Measured: 12 months post-hematopoietic stem-cell infusion]
Secondary outcomes (7)
1-Year Treatment-Related Mortality (TRM)
Cumulative incidence of non-relapse-related death after transplantation (competing risk: leukemia relapse).
Measured: 12 months post-transplantation
Cumulative Incidence of Relapse (CIR)
Cumulative probability of hematologic or molecular leukemia relapse with death as competing risk event.
Measured: 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.
Measured: Day 100, 1-year, 3-year post-transplantation
Overall Survival (OS)
Time from stem-cell infusion until death from any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: +1, +2, +3, +6, +12 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiao-Jun Huang, Principal investigator, Peking University Institute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919470
- Sponsor's protocol ID
- ALL-CR2-TBI-Bu
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Busulfan Based Versus Total Body Irradiation Based for Adults Acute B Lymphoblastic Leukemia in CR2: An Multicenter, Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT07919470
- Acronym / sponsor ID
- ALL-CR2-TBI-Bu
- Keywords
- acute lymphoblastic leukemia, allogeneic hematopoietic stem cell transplantation, conditioning regimen, total-body irradiation, busulfan, second complete remission, non-inferiority trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy-only Conditioning Regimen | Experimental | Drug: Chemotherapy-based Conditioning Regimenintervention： 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. |
| TBI-based Conditioning Regimen | Active comparator | Radiation: TBI-based conditioningintervention 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. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- Diagnosis of acute biphenotypic leukemia.
- Uncontrolled active infection at screening.
- Significant organ dysfunction:
- Participation in another investigational drug trial within past 3 months.
- Psychiatric disorders interfering with protocol compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy-based Conditioning RegimenExperimental 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. | Drug | Chemotherapy-only Conditioning Regimen |
| TBI-based conditioningActive 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. | Radiation | TBI-based Conditioning Regimen |
Primary outcome
1-Year Leukemia-Free Survival (LFS)
Time frame: 12 months post-hematopoietic stem-cell infusion]
Time from stem-cell infusion to leukemia relapse or death from any cause, whichever occurs first.
7 secondary outcomes
1-Year Treatment-Related Mortality (TRM)
Time frame: 12 months post-transplantation
Cumulative Incidence of Relapse (CIR)
Time frame: 1-year, 2-year, 3-year post-transplantation
Cumulative Incidence of Acute and Chronic Graft-Versus-Host Disease (GVHD)
Time frame: Day 100, 1-year, 3-year post-transplantation
Overall Survival (OS)
Time frame: 1-year, 2-year, 3-year post-transplantation
Conditioning-related organ toxicities
Time frame: Conditioning start up to post-transplant day +30
Hematopoietic engraftment
Time frame: Day 30 and Day 90 post-transplantation
Molecular/Flow-MRD status post-transplant
Time frame: +1, +2, +3, +6, +12 months post-transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao-Jun Huang principal investigator
Peking University Institute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy-based Conditioning Regimen and TBI-based conditioning in people with Acute Lymphoblastic Leukemia and Hematopoietic Stem Cell Transplantation, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Wang (8610-8832-6005, ywyw3172@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Leukemia-Free Survival (LFS) (time frame: 12 months post-hematopoietic stem-cell infusion]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.