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

Phase 2

Completed

• Conditions: Autologous Hematopoietic Stem Cell Transplantation; Acute Myeloid Leukemia; Conditioning
• Interventions: Drug: Idarubicin（IDA）; Drug: Busulfan (BU); Drug: Cyclophosphamide (CY)

• Registration Number: NCT02671708
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-30
• Study First Submitted QC: 2016-01-30
• Study First Posted: 2016-02-02
• Primary Completion: 2019-02-28
• Status Verified: 2019-03
• Study Completion: 2020-02-28
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Intermediate-risk AML
• Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens
• With negative MRD before mobilization and collect of peripheral blood stem cells
• Without HLA-matched donors (related and unrelated)
• Refusal of haploidentical hematopoietic stem cell transplantation

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IDA+BUCY	Idarubicin（IDA）	For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
IDA+BUCY	Busulfan (BU)	For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
IDA+BUCY	Cyclophosphamide (CY)	For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
BUCY	Busulfan (BU)	For intermediate-risk AML undergoing auto-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.
BUCY	Cyclophosphamide (CY)	For intermediate-risk AML undergoing auto-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.

Primary Outcome Measures

Name	Time	Method
leukemia relapse rate	2 year

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	2 year
disease-free survival (DFS)	2 year
transplant-related mortality (TRM)	2 year

Trial Locations

Locations (1)

Department of Hematology,Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China