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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 08, 2014