A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma
- Determine the safety and tolerability of monoclonal antibody hA20 in patients with
refractory CD20-positive B-cell non-Hodgkin's lymphoma.
- Determine the immunogenicity of this drug in these patients.
- Determine the pharmacodynamics and pharmacokinetics of this drug in these patients.
- Determine, preliminarily, the efficacy of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive monoclonal antibody hA20 IV once weekly for 4 weeks.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody hA20. Up to 10
additional patients are then entered at 1 or more dose levels to determine the optimal dose.
After completion of study treatment, patients are followed weekly for 4 weeks, at 8 and 12
weeks, and then every 3 months until disease progression.
PROJECTED ACCRUAL: Approximately 19-28 patients will be accrued for this study.
Primary Purpose: Treatment
William A. Wegener, MD, PhD
|New York Weill Cornell Cancer Center at Cornell University||New York, New York 10021|