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

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. Identifier: NCT01514344
Recruitment Status : Unknown
Verified January 2012 by Andres J. M. Ferreri, IRCCS San Raffaele.
Recruitment status was:  Recruiting
First Posted : January 23, 2012
Last Update Posted : January 23, 2012
Information provided by (Responsible Party):
Andres J. M. Ferreri, IRCCS San Raffaele

January 6, 2012
January 23, 2012
January 23, 2012
December 2011
October 2014   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma
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.
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.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma
  • 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
Experimental: intralesional rituximab
  • Drug: intralesional rituximab
  • Biological: supplemental autologous serum
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
October 2015
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Andres J. M. Ferreri, IRCCS San Raffaele
Andres J. M. Ferreri
Not Provided
Study Chair: Andrés JM Ferreri, MD San Raffaele Scientific Institute, Milano, Italy
IRCCS San Raffaele
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP