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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Andres J. M. Ferreri, IRCCS San Raffaele.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514344
First Posted: January 23, 2012
Last Update Posted: January 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andres J. M. Ferreri, IRCCS San Raffaele
  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: Intervention Model: Single Group Assignment
Masking: None (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 Andres J. M. Ferreri, IRCCS San Raffaele:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Andres J. M. Ferreri, MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01514344     History of Changes
Other Study ID Numbers: IRIS
First Submitted: January 6, 2012
First Posted: January 23, 2012
Last Update Posted: January 23, 2012
Last Verified: January 2012

Keywords provided by Andres J. M. Ferreri, 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
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents