Treatment of Primary CNS Lymphoma
FVD
The Prospective Study of FVD Program and HD-MTX-Ara-C Program Contrast in the Treatment of PCNSL Lymphoma.
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of FVD regiment (fotemustine, teniposide and dexamethasone ) for patients with primary CNS lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2012
Longer than P75 for phase_4
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
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 8, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJuly 21, 2015
July 1, 2015
4 years
October 8, 2013
July 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
up to end of follow-up-phase (approximately 24 months)
Secondary Outcomes (3)
response rate
every 6 weeks,up to completion of treatment(approximately 18 weeks )
overall survival
up to the date of death (approximately 5 years)
median survival time
24 months
Study Arms (2)
FVD regimen
EXPERIMENTALFVD regimen(fotemustine, teniposide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,teniposide 60mg/m2 d2-4 ivgtt,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles.
HD-MTX-Ara-C regimen
EXPERIMENTALhigh-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles.
Interventions
high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
FVD regimen(fotemustine, teniposide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,teniposide 60mg/m2 d2-4 ivgtt,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
Eligibility Criteria
You may qualify if:
- volunteers who signed informed consent. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mingzhi Zhanglead
- Zhengzhou Universitycollaborator
Study Sites (1)
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Study Officials
- PRINCIPAL INVESTIGATOR
Mingzhi Zhang, Pro,Dr
The First Affiliated Hospital of Zhengzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- the director of oncology department of the first affiliated hospital
Study Record Dates
First Submitted
October 8, 2013
First Posted
October 10, 2013
Study Start
June 1, 2012
Primary Completion
June 1, 2016
Study Completion
June 1, 2020
Last Updated
July 21, 2015
Record last verified: 2015-07