Back to resultsIntralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma (IRIS)
Primary Purpose
Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
intralesional rituximab
supplemental autologous serum
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma focused on measuring OAL, MALT, conjunctiva, indolent, CD20+
Eligibility Criteria
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
Sites / Locations
- Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intralesional rituximab
Arm Description
Outcomes
Primary Outcome Measures
assessment of safety
assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment
Secondary Outcome Measures
assessment of activity
assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01514344
Brief Title
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma
Acronym
IRIS
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andres J. M. Ferreri
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
Keywords
OAL, MALT, conjunctiva, indolent, CD20+
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intralesional rituximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
intralesional rituximab
Other Intervention Name(s)
Intraconjunctival rituximab; mabthera, anti-CD20 therapy
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
supplemental autologous serum
Other Intervention Name(s)
autologous serum supplementation; complement
Intervention Description
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
Primary Outcome Measure Information:
Title
assessment of safety
Description
assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment
Time Frame
During experimental treatment (within 7 months from trial registration)
Secondary Outcome Measure Information:
Title
assessment of activity
Description
assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response
Time Frame
at the end of experimental treatment (at 7th month from trial registration)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrés JM Ferreri, MD
Organizational Affiliation
San Raffaele Scientific Institute, Milano, Italy
Official's Role
Study Chair
Facility Information:
Facility Name
Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor
City
Milano
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
32182364
Citation
Ferreri AJM, Sassone M, Miserocchi E, Govi S, Cecchetti C, Corti ME, Mappa S, Arcaini L, Zaja F, Todeschini G, Mannina D, Calimeri T, Perrone S, Ponzoni M, Modorati G. Treatment of MALT lymphoma of the conjunctiva with intralesional rituximab supplemented with autologous serum. Blood Adv. 2020 Mar 24;4(6):1013-1019. doi: 10.1182/bloodadvances.2020001459.
Results Reference
derived
Learn more about this trial
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma
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