FVD: Treatment of Primary CNS Lymphoma

• Sponsor: Mingzhi Zhang (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01960192
• Collaborator: Zhengzhou University (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 96
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary CNS Lymphoma (PCNSL)	Drug: HD-MTX-Ara-C regimen; Drug: FVD regimen	Phase 4

Detailed Description

Primary CNS lymphoma (PCNSL) is a rare B-cell variant of non-Hodgkin lymphoma that is confined to the brain, leptomeninges, spinal cord, and eyes. The optimum treatment for patients with PCNSL remains challenging and at present there is no universally accepted therapeutic approach for patients with newly diagnosed disease. The purpose of this study is to evaluate the efficacy and safety of FVD regiment(fotemustine, teniposide and dexamethasone)contrast with HD-MTX-Ara-C program for patients with primary CNS lymphoma.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Prospective Study of FVD Program and HD-MTX-Ara-C Program Contrast in the Treatment of PCNSL Lymphoma.
• Study Start Date: Jun 1, 2012
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: 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
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.	Drug: 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

Outcome Measures

Primary Outcome Measures

1. Progression-free survival [up to end of follow-up-phase (approximately 24 months)]

Secondary Outcome Measures

1. response rate [every 6 weeks,up to completion of treatment(approximately 18 weeks )]

2. overall survival [up to the date of death (approximately 5 years)]

3. median survival time [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oncology Department of The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China	450052

Sponsors and Collaborators

• Mingzhi Zhang
• Zhengzhou University

Investigators

• Principal Investigator: Mingzhi Zhang, Pro,Dr, The First Affiliated Hospital of Zhengzhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University
• ClinicalTrials.gov Identifier: NCT01960192
• Other Study ID Numbers: hnslblzlzx2011-6
• First Posted: Oct 10, 2013
• Last Update Posted: Jul 21, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Mingzhi Zhang, the director of oncology department of the first affiliated hospital, Zhengzhou University: primary CNS lymphoma;chemotherapy;; RR;PFS;OS
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of Jul 21, 2015