BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

November 6, 2018 updated by: Qifa Liu, Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Department of Hematology,Nanfang Hospital, Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS
Time Frame: 2 year
disease-free survival (DFS)
2 year
relapse rate
Time Frame: 2 year
relapse rate
2 year
TRM
Time Frame: 2 year
transplant-related mortality (TRM)
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2018

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

November 6, 2018

First Submitted That Met QC Criteria

November 6, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUCYE-PCNSL-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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