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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 6, 2012

Last Updated Date

January 17, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01514344 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: intralesional rituximab

Interventions:

Drug: intralesional rituximab
Biological: supplemental autologous serum

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2015

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01514344

Other Study ID Numbers ^ICMJE

IRIS

Has Data Monitoring Committee

Responsible Party

Andres J. M. Ferreri, IRCCS San Raffaele

Study Sponsor ^ICMJE

Andres J. M. Ferreri

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Andrés JM Ferreri, MD

San Raffaele Scientific Institute, Milano, Italy

Information Provided By

IRCCS San Raffaele

Verification Date

January 2012

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

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