Trials / Completed
CompletedNCT02670252
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 550 (actual)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- All
- Age
- 14 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Busulfan
- Total Body Irradiation
- Acute Lymphocytic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Busulfan (BU) | Busulfan was administered at 3.2 mg/kg/day on days -7 to -4. |
| DRUG | Cyclophosphamide (CY) | Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2. |
| RADIATION | Total Body Irradiation (TBI) | Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2020-02-01
- Completion
- 2022-02-01
- First posted
- 2016-02-01
- Last updated
- 2022-04-08
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02670252. Inclusion in this directory is not an endorsement.