BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT | NCT03733327

Studies
BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

NCT03733327

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Nov 7, 2018Actual

Enrollment

20Estimated

Phase

Phase 2Phase 3

Conditions

Primary Central Nervous System Lymphoma
Autologous Hematopoietic Stem Cell Transplantation
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

Nov 2018

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

Nov 2018Estimated

Primary Completion Date

Oct 2021Estimated

Completion Date

Oct 2021Estimated

First Submitted Date

Nov 6, 2018

First Submission Date that Met QC Criteria

Nov 6, 2018

First Posted Date

Nov 7, 2018Actual

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

Nov 6, 2018

Last Update Posted Date

Nov 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qifa Liu, Prof., Nanfang Hospital, Southern Medical UniversityPrincipal Investigator

Lead Sponsor

Nanfang Hospital, Southern Medical UniversityOTHER

Collaborators

Name	Class
Peking University People's Hospital	OTHER
Guangzhou First People's Hospital	OTHER
Zhujiang Hospital	OTHER
Sun Yat-Sen Memorial Hospital of 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 BUCYE conditioning regimens in primary central nervous system lymphoma undergoing autologous hematopoietic stem cell transplantation.

Detailed Description

The prognosis of patients with primary central nervous system lymphoma (PCNSL) is poor. Recent studies have demonstrated that autologous hematopoietic stem cell transplantation (auto-HSCT) could improve the prognosis of these patients. However, the optimal conditioning regimen of auto-HSCT remains unclear. In this study, the investigators evaluated the safety and efficacy of BUCYE conditioning regimens in PCNSL undergoing auto-HSCT.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BUCYE	Experimental	For PCNSL patients undergoing auto-HSCT，BUCYE 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)

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.	BUCYE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OS	overall survival (OS)	2 year

Secondary Outcomes

Measure	Description	Time Frame
DFS	disease-free survival (DFS)	2 year
relapse rate	relapse rate	2 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary central nervous system lymphoma patients
Achieving CR or PR, then mobilizing and collecting of peripheral blood stem cells

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

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

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Browse Branches

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