Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma Clinical Trial
— IRISOfficial title:
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
NCT number | NCT01514344 |
Other study ID # | IRIS |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | December 2011 |
Est. completion date | October 2019 |
Verified date | August 2022 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.
Status | Completed |
Enrollment | 20 |
Est. completion date | October 2019 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor | Milano |
Lead Sponsor | Collaborator |
---|---|
Andres J. M. Ferreri |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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