BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

Primary Central Nervous System Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03733327
• Other study ID #: BUCYE-PCNSL-2018
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2018
• Est. completion date: October 2021

Study information

• Verified date: November 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Qifa Liu
• Phone: +862061641611
• Email: liuqifa628[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days-7 to -4.
• Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
• Etoposide (VP-16)
Etoposide was administered at 15 mg/kg/day on days -3 to -2.

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Guangzhou First People's Hospital, Peking University People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	overall survival (OS)	2 year
Secondary	DFS	disease-free survival (DFS)	2 year
Secondary	relapse rate	relapse rate	2 year
Secondary	TRM	transplant-related mortality (TRM)	2 year