Lymphoma Clinical Trial
Official title:
A Phase II Trial of C2B8 in Patients With Asymptomatic CD20+ B-Cell Follicular Small Cleaved Low-Grade Non-Hodgkin's Lymphoma or Relapsed CD20+ Hodgkin's Disease
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
cancer-killing substances to them.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who
have non-Hodgkin's lymphoma or Hodgkin's disease.
OBJECTIVES: I. Determine the response rate (complete or partial) to rituximab in previously
untreated patients with stage III or IV CD20+ B-cell follicular small cleaved cell
non-Hodgkin's lymphoma. II. Determine the response rate (complete or partial) to rituximab
in patients with relapsed CD20+ Hodgkin's disease. III. Determine the time to progression
and time to chemotherapy in these patients after treatment with rituximab.
OUTLINE: Patients are stratified according to disease (follicular small cleaved cell
non-Hodgkin's lymphoma vs relapsed Hodgkin's disease). Patients receive rituximab IV over
4-6 hours on day 1 weekly for 4 weeks. Patients are followed at 1, 3, 6, 9, and 12 months,
then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 21-32 patients will be accrued for each arm of this study
within 7-10.5 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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