Lymphoma Clinical Trial
Official title:
Biaxin(Clarithromycin)Based Antibiotic Therapy In Previously Untreated, Advanced Stage Indolent Lymphoma
The purpose of this study is to see if a treatment with Biaxin (clarithromycin) which is an antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the lymphoma. We would also like to see how Biaxin (clarithromycin) works on lymphoma and blood cells.There is some evidence that this medication may change the behavior of lymphocytes, in addition to its known anti-infection activity.
The primary objective of this study is to evaluate a biaxin (clarithromycin)-based
antibiotic therapy in previously untreated patients with indolent lymphoma who do not
require active lymphoma therapy (utilizing GELF criteria,). This is the primary objective
Response rate (CR + PR) stratified for Follicular/Non-Follicular disease.
The secondary objectives of this study are to understand the biologic correlates of indolent
lymphoma biaxin (clarithromycin) response and progression:
Response rate (CR + PR) according to H. pylori positive or negative (RR with a confidence
interval will be estimated for each subset). Immunohistochemistry in all diagnostic biopsy
specimens: Lymphocyte- Activated Macrophage (CD68) and other selected markers to clarify
tumor infiltrating cells. Peripheral blood mononuclear cell (PBMCs) studies to evaluate
possible HDAC (histone deacetylase) inhibition with biaxin (clarithromycin) therapy.
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Observational Model: Cohort, Time Perspective: Prospective
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