Lymphoma Clinical Trial
Official title:
Clinical Trial Of C2B8 Monoclonal Antibody Following High Dose Therapy And Autografting In B-Cell Non-Hodgkin's Lymphoma
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas,
but is limited by relapse occurs in 40 to 50% of subjects.
This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose
therapy increases the event-free survival in diffuse aggressive lymphomas and low grade
lymphomas, as an alternative to the limitations of conventional therapy.
Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about
50% with very little toxicity. Rituximab is hypothesized to be a candidate for
post-transplant therapy because the majority of malignant lymphomas express the CD20
antigen; rituximab has impressive independent anti-tumor activity; and the antibody has
little toxicity outside of the acute administration.
The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375
mg/m2, starting 6 weeks after ASCT transplant.
After an observation period to assess acute and late toxicity for the first 4 subjects,
subsequent subjects received induction as above followed by an additional 4 week course at
6-months post-ASCT.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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