Clinical Trial: Treatment of Primary CNS Lymphoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Prospective Study of FVD Program and HD-MTX-Ara-C Program Contrast in the Treatment of PCNSL Lymphoma.

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 Summary: 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.
Sponsor: Mingzhi Zhang

Current Primary Outcome: Progression-free survival [ Time Frame: up to end of follow-up-phase (approximately 24 months) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Zhengzhou University

Dates:
Date Received: October 8, 2013
Date Started: June 2012
Date Completion: June 2020
Last Updated: July 19, 2015
Last Verified: July 2015