Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-Cell Lymphoma
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
response rate
CR+PR with study therapy
No
Cheolwon Suh, MD, PhD
Principal Investigator
Asan Medical Center
Korea: Food and Drug Administration
AMC 2006-60
NCT00337259
June 2006
March 2009
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