Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
We hope to learn whether I-131 tositumomab combined with external beam radiation therapy is an effective means of treating relapsed, bulky non-Hodgkin's lymphoma. The purpose of the study is to determine the overall response rate with responses described as: Site-dependent and overall CR and functional CR (CR of CRu(Complete Response Unconfirmed)/PR with PET negativity), or PR rates.
At the present time over 1,600 patients have been treated with iodine I 131 tositumomab (Bexxar) in a variety of clinical trials. The overall clinical data demonstrate that patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma derive significant therapeutic benefit from iodine I 131 tositumomab. Data describing its safety and efficacy are available for over 700 patients. In aggregate, the data demonstrate that iodine I 131 tositumomab produces: 1) high overall and complete response rates, 2) clinically meaningful prolongations of response compared to those achieved after patients last prior therapies, 3) durable complete responses, and 4) manageable toxicity in patients with low grade or transformed non-Hodgkin's lymphoma. The purpose of this study is to study the safety and efficacy of this treatment in combination with external beam radiation in patients with relapsed bulky NHL. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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