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

This study is currently recruiting participants.
Verified January 2012 by IRCCS San Raffaele
Sponsor:
Information provided by (Responsible Party):
Andres J. M. Ferreri, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01514344
First received: January 6, 2012
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
Drug: intralesional rituximab
Biological: supplemental autologous serum
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • assessment of safety [ Time Frame: During experimental treatment (within 7 months from trial registration) ] [ Designated as safety issue: Yes ]
    assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment


Secondary Outcome Measures:
  • assessment of activity [ Time Frame: at the end of experimental treatment (at 7th month from trial registration) ] [ Designated as safety issue: Yes ]
    assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response


Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: autologous serum supplementation; complement

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514344

Contacts
Contact: Andrés JM Ferreri, MD +39022643 ext 7649 ferreri.andres@hsr.it
Contact: Silvia Govi, MD +39022643 ext 7612 govi.silvia@hsr.it

Locations
Italy
Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor Recruiting
Milano, Italy
Contact: Andrés JM Ferreri, MD    +39022643 ext 7649    ferreri.andres@hsr.it   
Contact: Silvia Govi, MD    +39022643 ext 7612    govi.silvia@hsr.it   
Principal Investigator: Andrés JM Ferreri, MD         
Sponsors and Collaborators
Andres J. M. Ferreri
Investigators
Study Chair: Andrés JM Ferreri, MD San Raffaele Scientific Institute, Milano, Italy
  More Information

No publications provided

Responsible Party: Andres J. M. Ferreri, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01514344     History of Changes
Other Study ID Numbers: IRIS
Study First Received: January 6, 2012
Last Updated: January 17, 2012
Health Authority: Italy: Ethics Committee
Italy: The Italian Medicines Agency

Keywords provided by IRCCS San Raffaele:
OAL
MALT
conjunctiva
indolent
CD20+

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014