CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 550 enrolled
Drug / intervention
Busulfan (BU) +2 moredrug
Likely dose
Busulfan (BU) 3.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02670252
NCT02670252Phase 3Completed
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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

Nanfang Hospital, Southern Medical University·interventional·Posted Feb 1, 2016·Updated Apr 8, 2022

In Brief

A Phase 3 clinical trial evaluating Busulfan (BU), Cyclophosphamide (CY), and 1 other intervention for Allogeneic Hematopoietic Stem Cell Transplantation and 3 related conditions. Completed, enrolled 550 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Total Body Irradiation, Acute Lymphocytic Leukemia
CountriesChina
CollaboratorsGuangzhou First People's Hospital, Zhujiang Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Zhengzhou University, Xiangya Hospital of Central South University, The Seventh Affiliated Hospital of Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University, Guangdong Second Provincial General Hospital, The Affiliated Hospital of Qingdao University, First People's Hospital of Chenzhou, Guangzhou Panyu Central Hospital

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 1, 2016
Enrollment StartJan 1, 2016
Primary CompletionFeb 1, 2020
Study CompletionFeb 1, 2022
TodayJul 1, 2026
Enrollment to primary: 4.1 yearsPosted 10.4 years ago

Interventions

Busulfan (BU)drug

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

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.