Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma (IRIS)

Andres J. M. Ferreri

Status and phase: Completed; Phase 2

Conditions: Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Treatments: Drug: intralesional rituximab; Biological: supplemental autologous serum

Study type: Interventional

Funder types: Other

Identifiers

NCT01514344

IRIS

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

intralesional rituximab

Experimental group

Treatment:

Biological: supplemental autologous serum

Drug: intralesional rituximab