IRIS: Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

Sponsor

Andres J. M. Ferreri (Other)

Overall Status

Completed

CT.gov ID

NCT01514344

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma	Drug: intralesional rituximab Biological: supplemental autologous serum	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intralesional rituximab	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 Names: 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 Names: autologous serum supplementation; complement

Arm

Intervention/Treatment

Experimental: intralesional rituximab

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 Names:

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 Names:

autologous serum supplementation; complement

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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