Phase II Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL)
New treatment modalities are needed for diffuse large cell B cell non-Hodgkin's lymphoma
(DLCL). Only 35-40% of patients with DLCL are curable with standard therapy. Therefore,
approximately 60-65% of DLCL patients subsequently need salvage therapy. Salvage regimens
(e.g. ESHAP, DHAP, (R)-ICE, etc) are very toxic, especially in elderly patients, and have a
response rate (RR) of only 45-60% in these patients. The median survival from the time of
relapse is less than one year and only a small fraction of such patients benefit from
autologous stem cell transplant (ASCT).
There is a lack of efficacious treatment options for patients with relapsed/refractory DLCL
who are not appropriate candidates for stem cell transplantation. DLCL is a relatively
radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20
monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a
rational and promising therapeutic approach for this patient population.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate and duration of response
4 years
No
Susan J Knox
Principal Investigator
Stanford University
United States: Food and Drug Administration
LYMNHL0019
NCT00490009
September 2004
February 2013
Name | Location |
---|---|
Stanford University School of Medicine | Stanford, California 94305-5317 |