BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03733327

Collaborator

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 (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Central Nervous System Lymphoma Autologous Hematopoietic Stem Cell Transplantation Conditioning	Drug: Busulfan (BU) Drug: Cyclophosphamide (CY) Drug: Etoposide (VP-16)	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BUCYE 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) 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.

Arm

Intervention/Treatment

Experimental: BUCYE

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)

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.

Outcome Measures

Primary Outcome Measures

OS [2 year]
overall survival (OS)

Secondary Outcome Measures

DFS [2 year]
disease-free survival (DFS)
relapse rate [2 year]
relapse rate
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:

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)

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
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

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, Prof., Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT03733327

Other Study ID Numbers:

BUCYE-PCNSL-2018

First Posted:

Nov 7, 2018

Last Update Posted:

Nov 7, 2018

Last Verified:

Nov 1, 2018

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:

Study Results

No Results Posted as of Nov 7, 2018