Clinical trial · Interventional
BuCY vs TBICY Conditioning Regimen for Standard-risk ALL Undergoing Allo-HSCT
Busulfan Plus Cyclophosphamide vs Total Body Irradiation Plus Cyclophosphamide Conditioning Regimen for Standard-risk Acute Lymphocytic Leukemia Undergoing HLA-matched Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice between BU-based or TBI-based conditioning regimens still remains controversial. In this study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Allogeneic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Busulfan | — | UNRESOLVED | — |
| Total Body Irradiation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan (BU) | Drug | Busulfan | ALIAS |
| Cyclophosphamide (CY) | Drug | Cyclophosphamide | ALIAS |
| Total Body Irradiation (TBI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BUCY
- description
- For standard-risk ALL undergoing HLA-matched allo-HSCT，BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
- interventionNames
- Drug: Busulfan (BU)
- Drug: Cyclophosphamide (CY)
- type
- ACTIVE_COMPARATOR
- label
- TBICY
- description
- For standard-risk ALL undergoing HLA-matched allo-HSCT，TBICY conditioning regimen was 4.5 Gy TBI/day on days -5 and -4；CY 60 mg/kg/day on days -3 and -2.
- interventionNames
- Drug: Cyclophosphamide (CY)
- Radiation: Total Body Irradiation (TBI)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Standard-risk ALL * Achieving CR1 * Undergoing HLA-matched allo-HSCT (related or unrelated) Exclusion Criteria: * Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
References
Publications (2)
- BACKGROUNDde Berranger E, Cousien A, Petit A, Peffault de Latour R, Galambrun C, Bertrand Y, Salmon A, Rialland F, Rohrlich PS, Vannier JP, Lutz P, Yakouben K, Duhamel A, Bruno B, Michel G, Dalle JH. Impact on long-term OS of conditioning regimen in allogeneic BMT for children with AML in first CR: TBI+CY versus BU+CY: a report from the Societe Francaise de Greffe de Moelle et de Therapie Cellulaire. Bone Marrow Transplant. 2014 Mar;49(3):382-8. doi: 10.1038/bmt.2013.185. Epub 2013 Dec 9. PMID 24317131
- DERIVEDZhang H, Fan Z, Huang F, Han L, Xu Y, Xu N, Deng L, Wang S, Lin D, Luo X, Zhang Q, Liu X, Li X, Liang X, Xie S, Qu H, Yu S, Zhou H, Shi P, Xuan L, Lin R, Liu H, Jin H, Sun J, Liu Q. Busulfan Plus Cyclophosphamide Versus Total Body Irradiation Plus Cyclophosphamide for Adults Acute B Lymphoblastic Leukemia: An Open-Label, Multicenter, Phase III Trial. J Clin Oncol. 2023 Jan 10;41(2):343-353. doi: 10.1200/JCO.22.00767. Epub 2022 Sep 9. PMID 36084276