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The Efficacy And Safety Of Patients With Non Hodgkin 's Lymphoma Essay

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even though these products are not developed according to the global biosimilar guidelines put in place in India in 2012, they have led to competitive pricing and greater affordability. iv. Clinical trial design, study endpoints, standard of care by country The study is a multi-center, randomized, open-label, study to evaluate the efficacy and safety of Rituximab in patients with Non-Hodgkin’s Lymphoma (NHL). The study will be conducted at up to 25 sites in the United States, France, Canada and India. The study will enroll up to 350 patients. The study population will include patient >18 years of age (both male and female); with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin’s lymphoma. Patients randomized to Rituximab will receive 400 mg intravenously (IV) every 3 weeks up to 12 months. Patients randomized to standard of care for chemotherapy will receive treatment per the Physician’s choice and recommended dosage. All patients will be followed for up to 24 months after last dose of study medications or until death. Overall response rate (ORR), progression-free survival (PFS), overall survival (OS) and clinical benefit will be determined. Patients will be randomized to receive Rituximab or standard of care. The standard of care in the United States, France, Canada and India is a combination CHOP (cyclophosphamide, doxorubicin HCl, oncovin, and prednisone) regimen with or without Rituximab. (Coiffier et al, 2005). Primary endpoints

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