- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01960192
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Henan
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Zhengzhou, Henan, China, 450052
- Recruiting
- Oncology Department of The First Affiliated Hospital of Zhengzhou University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Age range 14-60 years old; ECOG performance status 0-2; Estimated survival time > 3 months Histological confirmed PCNSL None of chemotherapy or radiotherapy has been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) At least one measurable lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of women at reproductive age must be negative Patients could be followed up None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
volunteers who signed informed consent. -
Exclusion Criteria:Disagreement on blood sample collection Patients allergic of any of drug in this regimen or with metabolic disorder Pregnant or lactating women Serious medical illness likely to interfere with participation Serious infection Primitive or secondary tumors of central nervous system Chemotherapy or radiotherapy contraindication The evidence of peripheral nervous disorder or dysphrenia patients participating in other clinical trials patients taking other antitumor drugs patients estimated to be unsuitable by investigato
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HD-MTX-Ara-C regimen
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.
|
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
|
Experimental: FVD regimen
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: up to end of follow-up-phase (approximately 24 months)
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up to end of follow-up-phase (approximately 24 months)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: up to the date of death (approximately 5 years)
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up to the date of death (approximately 5 years)
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median survival time
Time Frame: 24 months
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24 months
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response rate
Time Frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )
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every 6 weeks,up to completion of treatment(approximately 18 weeks )
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mingzhi Zhang, Pro,Dr, The First Affiliated Hospital of Zhengzhou University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- hnslblzlzx2011-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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