Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Intervention / Treatment
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* Drug: intralesional rituximab
* Biological: supplemental autologous serum


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intralesional rituximab<br> | Drug: intralesional rituximab<br>* 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<br>* Other names: Intraconjunctival rituximab; mabthera, anti-CD20 therapy;Biological: supplemental autologous serum<br>* 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<br>* Other names: autologous serum supplementation; complement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of safety | assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment | During experimental treatment (within 7 months from trial registration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of activity | assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response | at the end of experimental treatment (at 7th month from trial registration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OAL, MALT, conjunctiva, indolent, CD20+