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| Name | Class |
|---|---|
| Guangzhou First People's Hospital | OTHER |
| Zhujiang Hospital | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University |
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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.
Allo-HSCT appears to be an efficient tool to cure standard-risk ALL in CR1. The conditioning regimen with BUCY or TBICY is considered as the standard myeloablative regimen for ALL in CR1, but the choice between BU-based or TBI-based conditioning regimen still remains controversial.In order to analyze the impact of conditioning regimen on long-term survival and relapse, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUCY | Experimental | 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. |
|
| TBICY | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Busulfan (BU) | Drug | Busulfan was administered at 3.2 mg/kg/day on days -7 to -4. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| leukemia relapse rate | 2 year | |
| disease-free survival (DFS) | 2 year | |
| transplant-related mortality (TRM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24317131 | Background | de 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. | |
| 36084276 |
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| OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| The Seventh Affiliated Hospital of Sun Yat-sen University | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| Guangdong Second Provincial General Hospital | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| First People's Hospital of Chenzhou | OTHER |
| Guangzhou Panyu Central Hospital | OTHER |
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| Cyclophosphamide (CY) |
| Drug |
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2. |
|
| Total Body Irradiation (TBI) | Radiation | Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4. |
|
| 2 year |
| Derived |
| Zhang 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. |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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