CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 153 enrolled
Drug / intervention
Idarubicin（IDA） +2 moredrug
Likely dose
Idarubicin（IDA） 15mg/m2from record
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Search/NCT02671708
NCT02671708Phase 3Completed
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Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation

Nanfang Hospital, Southern Medical University·interventional·Posted Feb 2, 2016·Updated Mar 3, 2020

In Brief

A Phase 3 clinical trial evaluating Idarubicin（IDA）, Busulfan (BU), and 1 other intervention for Autologous Hematopoietic Stem Cell Transplantation and 2 related conditions. Completed, enrolled 153 participants across 1 site.

Detailed Summary

Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutologous Hematopoietic Stem Cell Transplantation, Acute Myeloid Leukemia, Conditioning
CountriesChina
CollaboratorsThird Affiliated Hospital, Sun Yat-Sen University, Peking University People's Hospital, Zhujiang Hospital, Guangzhou First People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 2, 2016
Enrollment StartJan 1, 2016
Primary CompletionFeb 28, 2019
Study CompletionFeb 28, 2020
TodayJul 1, 2026
Enrollment to primary: 3.2 yearsPosted 10.4 years ago

Interventions

Idarubicin（IDA）drug

Idarubicin was administered at 15mg/m2/day on days -12 and -10.

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.