BuCY vs TBICY Conditioning Regimen for Standard-risk ALL Undergoing Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Total Body Irradiation, Acute Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: Busulfan (BU)
* Drug: Cyclophosphamide (CY)
* Radiation: Total Body Irradiation (TBI)


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUCY<br>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. | Drug: Busulfan (BU)<br>* Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.<br>Drug: Cyclophosphamide (CY)<br>* Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.<br>|
| Active Comparator: TBICY<br>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. | Drug: Cyclophosphamide (CY)<br>* Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.<br>Radiation: Total Body Irradiation (TBI)<br>* Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leukemia relapse rate |  | 2 year | 
| disease-free survival (DFS) |  | 2 year | 
| transplant-related mortality (TRM) |  | 2 year |