Phase II Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease
- Determine the partial and complete response rates in patients with untreated or
recurrent/refractory lymphocyte predominant Hodgkin's lymphoma treated with rituximab.
- Determine the efficacy of this regimen in terms of duration of disease free survival
and time to progression in this patient population.
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive rituximab IV over several hours once a week for 4 weeks followed
by maintenance rituximab at 6, 12, and 18 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within
approximately 18 months.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival by Kaplan-Meie
Ranjana Hira Advani
United States: Food and Drug Administration
|Stanford University Medical Center||Stanford, California 94305-5408|
|Stanford University School of Medicine||Stanford, California 94305-5317|