BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergoing Auto-HSCT

Phase 2

• Conditions: Diffuse Large B-cell Lymphoma; Autologous Hematopoietic Stem Cell Transplantation; Conditioning
• Interventions: Drug: Busulfan (BU); Drug: Cyclophosphamide (CY); Drug: Etoposide (VP-16)

• Registration Number: NCT03229616
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous hematopoietic stem cell transplantation.

Detailed Description

Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective therapy for diffuse large B-cell lymphoma (DLBCL).BuCY conditioning regimen is a conventional scheme for DLBCL patients undergoing auto-HSCT, but it has a high relapse rate. Etoposide (VP-16) is extensively used in chemotherapy regimen for refractory/relapsed lymphoma. Whether addition of VP-16 could reduce the relapse rate remains unclear.In this study, the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in DLBCL undergoing auto-HSCT are evaluated.

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-05
• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-07-23
• Study First Posted: 2017-07-25
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Diffuse large B-cell lymphoma patients
• Achieving CR or PR after four cycles of chemotherapy, then mobilizing and collecting of peripheral blood stem cells and receiving one cycle of chemotherapy

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
BUCY	Cyclophosphamide (CY)	For DLBCL patients 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+VP-16	Etoposide (VP-16)	For DLBCL patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2; VP-16 15mg/kg/day on days -3 and -2.
BUCY+VP-16	Busulfan (BU)	For DLBCL patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2; VP-16 15mg/kg/day on days -3 and -2.
BUCY	Busulfan (BU)	For DLBCL patients 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+VP-16	Cyclophosphamide (CY)	For DLBCL patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2; VP-16 15mg/kg/day on days -3 and -2.

Primary Outcome Measures

Name	Time	Method
relapse rate	2 year	relapse rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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