Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

Phase 2

Completed

• Conditions: Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
• Interventions: Drug: intralesional rituximab; Biological: supplemental autologous serum

• Registration Number: NCT01514344
• Lead Sponsor: Andres J. M. Ferreri

Brief 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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-23
• Primary Completion: 2014-10
• Study Completion: 2019-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• histological diagnosis of CD20+ B cell lymphoma subtypes: marginal zone lymphoma, grade 1-2 follicular lymphoma, plasmocytic lymphoma, small lymphocyte lymphoma
• conjunctival localization alone (1EA stage; mono- or bilateral)
• at least one measurable lesion
• age >/= 18 years
• ECOG-PS </=3
• HIV 1-2 negativity
• at least one previous treatment (antibiotic or rituximab)

Exclusion Criteria

• concomitant conventional (chemo-, radiation, immuno-), experimental (antibiotic) or corticosteroid anticancer therapy
• known allergy to rituximab
• systemic symptoms
• concurrent diagnosis of pemphigus
• postsurgical conjunctival scars

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intralesional rituximab	supplemental autologous serum	-
intralesional rituximab	intralesional rituximab	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
assessment of activity	at the end of experimental treatment (at 7th month from trial registration)	assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response

Trial Locations

Locations (1)

Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor; 🇮🇹 Milano, Italy