Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell 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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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