BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergo... | NCT03229616

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

NCT03229616

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Oct 12, 2017Actual

Enrollment

122Estimated

Phase

Phase 2Phase 3

Conditions

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

Interventions

Busulfan (BU)
Cyclophosphamide (CY)
Etoposide (VP-16)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2017Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Jul 23, 2017

First Submission Date that Met QC Criteria

Jul 23, 2017

First Posted Date

Jul 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qifa Liu, Professor, Nanfang Hospital, Southern Medical UniversityPrincipal Investigator

Lead Sponsor

Nanfang Hospital, Southern Medical UniversityOTHER

Collaborators

Name	Class
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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BUCY+VP-16	Experimental	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) Drug: Cyclophosphamide (CY) Drug: Etoposide (VP-16)
BUCY	Active Comparator	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) Drug: Cyclophosphamide (CY)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Busulfan (BU)	Drug	Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.	BUCY BUCY+VP-16

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
relapse rate	relapse rate	2 year

Secondary Outcomes

Measure	Description	Time Frame
DFS	disease-free survival (DFS)	2 year
OS	overall survival (OS)	2 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qifa Liu	Contact	+862061641611		liuqifa628@163.com

Overall Officials

Name	Affiliation	Role
Qifa Liu	Nanfang Hospital, Southern Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Hematology,Nanfang Hospital, Southern Medical University	Recruiting	Guangzhou	Guangdong	510515	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016403	Lymphoma, Large B-Cell, Diffuse

Ancestor Terms

ID	Term
D016393	Lymphoma, B-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002066	Busulfan
D003520	Cyclophosphamide
D005047	Etoposide

Ancestor Terms

ID	Term
D002072	Butylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided