Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergoing Auto-HSCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03229616
Recruitment Status : Unknown
Verified July 2017 by Qifa Liu, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : July 25, 2017
Last Update Posted : October 12, 2017
Sponsor:
Collaborators:
Guangzhou First People's Hospital
Zhujiang Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital
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 BUCY+VP-16 and BUCY myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous hematopoietic stem cell transplantation.

Condition or disease Intervention/treatment Phase
Autologous Hematopoietic Stem Cell Transplantation Diffuse Large B-cell Lymphoma Conditioning Drug: Busulfan (BU) Drug: Cyclophosphamide (CY) Drug: Etoposide (VP-16) Phase 2 Phase 3

Detailed Description:
Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective therapy for diffuse large B-cell lymphoma (DLBCL).BuCY conditioning regimen is a conventional scheme for DLBCL patients undergoing auto-HSCT, but it has a high relapse rate. Etoposide (VP-16) is extensively used in chemotherapy regimen for refractory/relapsed lymphoma. Whether addition of VP-16 could reduce the relapse rate remains unclear.In this study, the safety and efficacy of BUCY+VP-16 and BUCY myeloablative conditioning regimens in DLBCL undergoing auto-HSCT are evaluated.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Busulfan+ Cyclophosphamide+ Etoposide vs Busulfan+ Cyclophosphamide Conditioning Regimen for Diffuse Large B-cell Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: BUCY+VP-16
For DLBCL patients undergoing auto-HSCT,BUCY+VP-16 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.

Active Comparator: BUCY
For DLBCL patients undergoing auto-HSCT,BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4;CY 60 mg/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.




Primary Outcome Measures :
  1. relapse rate [ Time Frame: 2 year ]
    relapse rate


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

  2. OS [ Time Frame: 2 year ]
    overall survival (OS)

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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:

  • Diffuse large B-cell lymphoma patients
  • Achieving CR or PR after four cycles of chemotherapy, then mobilizing and collecting of peripheral blood stem cells and receiving one cycle of chemotherapy

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): NCT03229616


Contacts
Layout table for location contacts
Contact: Qifa Liu +862061641611 liuqifa628@163.com

Locations
Layout table for location information
China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Li Xuan    +86-020-61641613    356135708@qq.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Guangzhou First People's Hospital
Zhujiang Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Peking University People's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University
Layout table for additonal information
Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03229616    
Other Study ID Numbers: BUCY+VP-16 vs BUCY-DLBCL-2017
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Busulfan
Etoposide
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