Treatment of Primary CNS Lymphoma (FVD)

• ClinicalTrials.gov Identifier: NCT01960192
• Recruitment Status: Unknown
• First Posted: October 10, 2013
• Last Update Posted: July 21, 2015
• Sponsor: Mingzhi Zhang
• Collaborator: Zhengzhou University
• Information provided by (Responsible Party): Mingzhi Zhang, Zhengzhou University

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 (Clinical Trial)
• Estimated 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: June 2012
• Estimated Primary Completion Date: June 2016
• Estimated Study Completion Date: June 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 [ Time Frame: up to end of follow-up-phase (approximately 24 months) ]

Secondary Outcome Measures :

1. response rate [ Time Frame: every 6 weeks,up to completion of treatment(approximately 18 weeks ) ]
2. overall survival [ Time Frame: up to the date of death (approximately 5 years) ]
3. median survival time [ Time Frame: 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 60 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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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Contacts and Locations

Contacts

Contact: Mingzhi zhang, Pro，Dr; 13838565629; Mingzhi_zhang@126.com

Locations

China, Henan

Oncology Department of The First Affiliated Hospital of Zhengzhou University; Recruiting

Zhengzhou, Henan, China, 450052

Contact: Mingzhi Zhang, Pro,Dr 13838565629 mingzhi_zhang@126.com

Sponsors and Collaborators

Mingzhi Zhang

Zhengzhou University

Investigators

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

More Information

• 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: October 10, 2013
• Last Update Posted: July 21, 2015
• Last Verified: July 2015

Keywords provided by Mingzhi Zhang, Zhengzhou University:

primary CNS lymphoma;chemotherapy; RR;PFS;OS

Additional relevant MeSH terms:

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases