Status:
COMPLETED
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma
Lead Sponsor:
Andres J. M. Ferreri
Conditions:
Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 se...
Eligibility Criteria
Inclusion
- 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
- concomitant conventional (chemo-, radiation, immuno-), experimental (antibiotic) or corticosteroid anticancer therapy
- known allergy to rituximab
- systemic symptoms
- concurrent diagnosis of pemphigus
- postsurgical conjunctival scars
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01514344
Start Date
December 1 2011
End Date
October 1 2019
Last Update
August 4 2022
Active Locations (1)
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1
Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
Milan, Italy