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 (IRIS)

NCT01514344 Phase 2 COMPLETED

Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.

Details

Lead sponsor	Andres J. M. Ferreri
Phase	Phase 2
Status	COMPLETED
Enrolment	20
Start date	2011-12
Completion	2019-10

Conditions

• Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Interventions

• intralesional rituximab
• supplemental autologous serum

Primary outcomes

• assessment of safety — During experimental treatment (within 7 months from trial registration)
  assessment of safety of intralesional rituximab in terms of incidence of \>/= G4 adverse events during the experimental treatment

Countries

Italy