BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergoing Auto-HSCT
Busulfan+ Cyclophosphamide+ Etoposide vs Busulfan+ Cyclophosphamide Conditioning Regimen for Diffuse Large B-cell Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
122
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2017
CompletedFirst Submitted
Initial submission to the registry
July 23, 2017
CompletedFirst Posted
Study publicly available on registry
July 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedOctober 12, 2017
July 1, 2017
2.9 years
July 23, 2017
October 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
relapse rate
relapse rate
2 year
Secondary Outcomes (3)
DFS
2 year
OS
2 year
TRM
2 year
Study Arms (2)
BUCY+VP-16
EXPERIMENTALFor 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.
BUCY
ACTIVE COMPARATORFor 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.
Interventions
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Eligibility Criteria
You may qualify if:
- 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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Guangzhou First People's Hospitalcollaborator
- Zhujiang Hospitalcollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Peking University People's Hospitalcollaborator
Study Sites (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 23, 2017
First Posted
July 25, 2017
Study Start
July 5, 2017
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
October 12, 2017
Record last verified: 2017-07