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NCT03733327 Clinical Trial

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
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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)

Study Design

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
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