Phase II Study on Activity and Tolerability of Intralesional Rituximab in Patients With Relapsed or Refractory CD20+ Indolent Lymphomas of Conjunctiva; Activity of Supplemental Autologous Serum in Patients Not Responsive to Rituximab Alone
Preliminary data suggest intralesional rituximab is able to revert resistance to systemic
rituximab in patients with CD20+ indolent lymphoma of the conjunctiva, and the addition of
autologous serum seems to exhibit a synergistic effect on tumor regression. These two main
aspects will be assessed in this trial.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
assessment of safety
assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment
During experimental treatment (within 7 months from trial registration)
Yes
Andrés JM Ferreri, MD
Study Chair
San Raffaele Scientific Institute, Milano, Italy
Italy: Ethics Committee
IRIS
NCT01514344
December 2011
October 2015
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