Gemcitabine for Marginal Zone Lymphoma
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.
Marginal Zone Lymphoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-Cell Lymphoma|
- response rate [ Time Frame: CR+PR with study therapy ] [ Designated as safety issue: No ]
- duration of response [ Time Frame: from best response to progression ] [ Designated as safety issue: No ]
- safety and tolerability of the treatment [ Time Frame: toxicity due to stdy drug ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337259
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Cheolwon Suh, MD, PhD||Asan Medical Center|