BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

NCT03733327 | Unknown Phase 2 DMC

• 1 other identifier: BUCYE-PCNSL-2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• OS

  overall survival (OS)

  2 year

Secondary Outcomes (3)

• DFS

  2 year

• relapse rate

  2 year

• TRM

  2 year

Study Arms (1)

BUCYE

EXPERIMENTAL

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); Drug: Cyclophosphamide (CY); Drug: Etoposide (VP-16)

Interventions

Busulfan (BU) DRUG

Busulfan was administered at 3.2 mg/kg/day on days-7 to -4.

BUCYE

Cyclophosphamide (CY) DRUG

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

BUCYE

Etoposide (VP-16) DRUG

Etoposide was administered at 15 mg/kg/day on days -3 to -2.

BUCYE

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary central nervous system lymphoma patients
• Achieving CR or PR, then mobilizing and collecting of peripheral blood stem cells

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Peking University People's Hospital: collaborator
• Guangzhou First People's Hospital: collaborator
• Zhujiang Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Interventions

Busulfan; Cyclophosphamide; Etoposide

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Qifa Liu

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qifa Liu

CONTACT

+862061641611; liuqifa628@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 7, 2018
• Study Start: November 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

CN (1)