Treatment of Primary CNS Lymphoma

NCT ID: NCT01960192

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2020-06-30

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.

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.

Conditions

Primary CNS Lymphoma (PCNSL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FVD regimen

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

HD-MTX-Ara-C regimen

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

volunteers who signed informed consent. -

Exclusion Criteria

-

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhengzhou University

OTHER

Sponsor Role: collaborator

Mingzhi Zhang

OTHER

Sponsor Role: lead

Responsible Party

Mingzhi Zhang

the director of oncology department of the first affiliated hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mingzhi Zhang, Pro,Dr

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

Oncology Department of The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingzhi zhang, Pro，Dr

Role: CONTACT

Mingzhi_zhang@126.com

13838565629

Facility Contacts

Mingzhi Zhang, Pro,Dr

Role: primary

mingzhi_zhang@126.com

13838565629

Other Identifiers

hnslblzlzx2011-6

Identifier Type: -

Identifier Source: org_study_id