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

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The study is a multi-center, randomized, open-label to evaluate the efficacy and safety of the Rituximab in patients with Non-Hodgkin’s Lymphoma (NHL). The study will be lead up to 25 sites in the USA, France, Canada and India. The study will enroll up to 1500 patients. The study population will include a patient >18 years of age (both male and female); with recurrence or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin’s lymphoma. Patients are selected randomized to receive Rituximab 400 mg intravenous (IV) every 3 weeks up to1 year. Patients are randomized to the standard of care for chemotherapy will get treatment as per the Physician’s choice and suggested dosage. All patients will be called for the follow up for up to 2 years after last dose of drug or until the death. The overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and clinical advantage will be observed. Patients will be selected randomized to obtain Rituximab or standard of care. The standard of care in the United States, France, Canada and India is an arrangement with CHOP (cyclophosphamide, doxorubicin HCl, oncovin, and prednisone) regimen with or without Rituximab. (Coiffier et al, 2005). Primary endpoints are to assess the overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). Secondary endpoint is to assess a clinical benefit rate, safety and tolerability in this population. v. Marketing applications requirements

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