Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma Clinical Trial

— IRIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514344
• Other study ID #: IRIS
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Est. completion date: October 2019

Study information

• Verified date: August 2022
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2019
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Intervention

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

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

Locations

Country	Name	City	State
Italy	Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Andres J. M. Ferreri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of safety	assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment	During experimental treatment (within 7 months from trial registration)
Secondary	assessment of activity	assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response	at the end of experimental treatment (at 7th month from trial registration)