NCT02671708

IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT

Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Auto-HSCT is an effective alternative to allogeneic HSCT for intermediate-risk AML without HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen. However, auto-HSCT with BUCY conditioning regimen appears to have higher relapse rate. To reduce the relapse rate, IDA is added in the conditioning regimen. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML patients undergoing auto-HSCT are evaluated.

Conditions

• Autologous Hematopoietic Stem Cell Transplantation
• Acute Myeloid Leukemia
• Conditioning

Interventions

Type	Name	Description
DRUG	Idarubicin（IDA）	Idarubicin was administered at 15mg/m2/day on days -12 and -10.
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-02-28
• Completion: 2020-02-28
• First posted: 2016-02-02
• Last updated: 2020-03-03

Locations

1 site across 1 country: China