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

Primary Purpose

Autologous Hematopoietic Stem Cell Transplantation, Diffuse Large B-cell Lymphoma, Conditioning

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Busulfan (BU)

Cyclophosphamide (CY)

Etoposide (VP-16)

About this trial

This is an interventional treatment trial for Autologous Hematopoietic Stem Cell Transplantation

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Hematology,Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BUCY+VP-16

BUCY

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

relapse rate

Secondary Outcome Measures

DFS

disease-free survival (DFS)

overall survival (OS)

TRM

transplant-related mortality (TRM)

Full Information

NCT ID

NCT03229616

First Posted

July 23, 2017

Last Updated

October 11, 2017

Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03229616

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 5, 2017 (Actual)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autologous Hematopoietic Stem Cell Transplantation, Diffuse Large B-cell Lymphoma, Conditioning

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BUCY+VP-16

Arm Type

Experimental

Arm Description

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.

Arm Title

BUCY

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Busulfan (BU)

Intervention Description

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide (CY)

Intervention Description

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Intervention Type

Drug

Intervention Name(s)

Etoposide (VP-16)

Intervention Description

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

Primary Outcome Measure Information:

Title

relapse rate

Description

relapse rate

Time Frame

2 year

Secondary Outcome Measure Information:

Title

DFS

Description

disease-free survival (DFS)

Time Frame

2 year

Title

Description

overall survival (OS)

Time Frame

2 year

Title

TRM

Description

transplant-related mortality (TRM)

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qifa Liu

Phone

+862061641611

liuqifa628@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qifa Liu

Organizational Affiliation

Nanfang Hospital, Southern Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Hematology,Nanfang Hospital, Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li Xuan

Phone

+86-020-61641613

356135708@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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