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.
Study Type
OBSERVATIONAL
Enrollment
36
Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
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,).
Time frame: conclusion of study
The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression
Time frame: conclusion of study
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