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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01514344

Acronym

IRIS

Enrollment

Registered

2012-01-23

Start date

2011-12-31

Completion date

2019-10-31

Last updated

2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Keywords

OAL, MALT, conjunctiva, indolent, CD20+

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.

Interventions

DRUGintralesional 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

BIOLOGICALsupplemental 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
assessment of safety	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

Measure	Time frame	Description
assessment of activity	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026