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BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT

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ClinicalTrials.gov Identifier: NCT03733327
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021


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.




Primary Outcome Measures :
  1. OS [ Time Frame: 2 year ]
    overall survival (OS)


Secondary Outcome Measures :
  1. DFS [ Time Frame: 2 year ]
    disease-free survival (DFS)

  2. relapse rate [ Time Frame: 2 year ]
    relapse rate

  3. TRM [ Time Frame: 2 year ]
    transplant-related mortality (TRM)



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733327


Contacts
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Contact: Qifa Liu +862061641611 liuqifa628@163.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Li Xuan    +86-020-62787883    356135708@qq.com   
Principal Investigator: Qifa Liu         
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
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Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University

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Responsible Party: Qifa Liu, Prof., Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03733327     History of Changes
Other Study ID Numbers: BUCYE-PCNSL-2018
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Busulfan
Etoposide
Etoposide phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors