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

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 3

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Acute Lymphocytic Leukemia; Total Body Irradiation; Busulfan

Treatments: Drug: Cyclophosphamide (CY); Radiation: Total Body Irradiation (TBI); Drug: Busulfan (BU)

Study type: Interventional

Funder types: Other

Identifiers

NCT02670252

BUCY vs TBICY-ALL-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 550 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

BUCY

Experimental group

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.

Treatment:

Drug: Cyclophosphamide (CY)

Drug: Busulfan (BU)

TBICY

Active Comparator group

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.

Treatment:

Drug: Cyclophosphamide (CY)

Radiation: Total Body Irradiation (TBI)