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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- assessment of safety
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
intralesional rituximab
Intervention: intralesional rituximab (Drug)
intralesional rituximab
Intervention: supplemental autologous serum (Biological)
Outcomes
Primary Outcomes
assessment of safety
Time Frame: 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 Outcomes
- assessment of activity(at the end of experimental treatment (at 7th month from trial registration))
Investigators
Andres J. M. Ferreri
MD
IRCCS San Raffaele