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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03229616

Collaborator

Guangzhou First People's Hospital (Other), Zhujiang Hospital (Other), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other), Peking University People's Hospital (Other)

122

Enrollment

Location

Arms

34.9

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autologous Hematopoietic Stem Cell Transplantation Diffuse Large B-cell Lymphoma Conditioning	Drug: Busulfan (BU) Drug: Cyclophosphamide (CY) Drug: Etoposide (VP-16)	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Busulfan+ Cyclophosphamide+ Etoposide vs Busulfan+ Cyclophosphamide Conditioning Regimen for Diffuse Large B-cell Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation

Actual Study Start Date :

Jul 5, 2017

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BUCY+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.	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. Drug: Etoposide (VP-16) Etoposide was administered at 15 mg/kg/day on days -3 to -2.
Active Comparator: BUCY 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.	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.

Arm

Intervention/Treatment

Experimental: BUCY+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.

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.

Drug: Etoposide (VP-16)

Etoposide was administered at 15 mg/kg/day on days -3 to -2.

Active Comparator: BUCY

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.

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.

Outcome Measures

Primary Outcome Measures

relapse rate [2 year]
relapse rate

Secondary Outcome Measures

DFS [2 year]
disease-free survival (DFS)
OS [2 year]
overall survival (OS)
TRM [2 year]
transplant-related mortality (TRM)

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University
Guangzhou First People's Hospital
Zhujiang Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital

Investigators

Principal Investigator: Qifa Liu, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qifa Liu, Professor, Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT03229616

Other Study ID Numbers:

BUCY+VP-16 vs BUCY-DLBCL-2017

First Posted:

Jul 25, 2017

Last Update Posted:

Oct 12, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell

Lymphoma, Large B-Cell, Diffuse

Cyclophosphamide

Busulfan

Etoposide

Study Results

No Results Posted as of Oct 12, 2017