NCT01514344

Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Andres J. M. Ferreri · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Interventions

Type	Name	Description
DRUG	intralesional rituximab	10-20 mg (1-2 ml) rituximab once a week for 4 weeks; followed by 10-20 mg (1-2 ml) rituximab monthly per six months
BIOLOGICAL	supplemental autologous serum	patients in PD or SD during or after administration of 6 doses monthly rituximab will be administered the same dose of intralesional rituximab supplemented by autologous serum

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-10-01
• Completion: 2019-10-01
• First posted: 2012-01-23
• Last updated: 2022-08-04

Locations

1 site across 1 country: Italy