Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine percentage of patients with CR at 12 weeks (CR or CRu/PR with PET negativity)
12 weeks
Yes
Susan J Knox
Principal Investigator
Stanford University
United States: Institutional Review Board
LYMNHL0046
NCT00490490
January 2007
December 2015
Name | Location |
---|---|
Stanford University School of Medicine | Stanford, California 94305-5317 |