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

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

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.

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