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BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

Primary Purpose

Primary Central Nervous System Lymphoma, Autologous Hematopoietic Stem Cell Transplantation, 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 Primary Central Nervous System Lymphoma

Eligibility Criteria

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

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)

Sites / Locations

Department of Hematology,Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BUCYE

Arm Description

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.

Outcomes

Primary Outcome Measures

overall survival (OS)

Secondary Outcome Measures

DFS

disease-free survival (DFS)

relapse rate

TRM

transplant-related mortality (TRM)

Full Information

NCT ID

NCT03733327

First Posted

November 6, 2018

Last Updated

November 6, 2018

Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03733327

Brief Title

BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

Official Title

Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Primary Central Nervous System Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2018 (Anticipated)

Primary Completion Date

October 2021 (Anticipated)

Study Completion Date

October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

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

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 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.

6. Conditions and Keywords

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

Primary Central Nervous System Lymphoma, Autologous Hematopoietic Stem Cell Transplantation, Conditioning

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BUCYE

Arm Type

Experimental

Arm Description

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.

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

Description

overall survival (OS)

Time Frame

2 year

Secondary Outcome Measure Information:

Title

DFS

Description

disease-free survival (DFS)

Time Frame

2 year

Title

relapse rate

Description

relapse rate

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: 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)

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

+86-020-62787883

356135708@qq.com

First Name & Middle Initial & Last Name & Degree

Qifa Liu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

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