Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma (IRIS)

August 2, 2022 updated by: Andres J. M. Ferreri

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

Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intralesional rituximab
Drug: intralesional rituximab
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
Other Names:
  • Intraconjunctival rituximab; mabthera, anti-CD20 therapy
Biological: supplemental autologous serum
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
Other Names:
  • autologous serum supplementation; complement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During experimental treatment (within 7 months from trial registration)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of activity
Time Frame: at the end of experimental treatment (at 7th month from trial registration)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andres J. M. Ferreri

Investigators

  • Study Chair: Andrés JM Ferreri, MD, San Raffaele Scientific Institute, Milano, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 23, 2012

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRIS (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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