Clinical Trial: Gemcitabine for Marginal Zone Lymphoma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
Brief Summary: Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. To the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.
Detailed Summary:
We designed a multi-center phase II trial of gemcitabine for advanced stage marginal zone B-cell lymphoma. Marginal zone lymphoma needs novel agent to improve clinical course by chemotherapy. Recent trials with new agents for indolent lymphoma shows promising results. Gemcitabine is known to have activity to non-Hodgkin's lymphoma and has less adverse effects than other new agents. With this background gemcitabine will be tried as a single agent for advanced marginal zone lymphoma.
Gemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. Response will be assessed by IWC criteria.
Sponsor: Asan Medical Center
Current Primary Outcome: response rate [ Time Frame: CR+PR with study therapy ]
Original Primary Outcome:
- response rate
- duration of response
Current Secondary Outcome: safety and tolerability of the treatment [ Time Frame: toxicity due to stdy drug ]
Original Secondary Outcome:
- safety and tolerability of the treatment
- progression free survival
- overall survival
Information By: Asan Medical Center
Dates:
Date Received: June 14, 2006
Date Started: June 2006
Date Completion:
Last Updated: February 13, 2016
Last Verified: February 2016
