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Completed

NCT Number: NCT01514344

Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

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

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Key information

Conditions

Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intralesional rituximab

Drug

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 names: Intraconjunctival rituximab; mabthera, anti-CD20 therapy

supplemental autologous serum

Biological

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 names: autologous serum supplementation; complement

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Andres J. M. Ferreri

Other

Registry information

Official study 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

Acronym: IRIS

Important dates

Study start
2011
Primary completion
2014
Study completion
2019
First posted
Jan 23, 2012
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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