Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma

NCT ID: NCT01514344

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2019-10-31

Brief Summary

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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

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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.

Conditions

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Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intralesional rituximab

Group Type EXPERIMENTAL

intralesional rituximab

Intervention Type 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

supplemental autologous serum

Intervention Type 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

Interventions

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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

Intervention Type DRUG

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Intraconjunctival rituximab; mabthera, anti-CD20 therapy autologous serum supplementation; complement

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Andres J. M. Ferreri

OTHER

Sponsor Role lead

Responsible Party

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Andres J. M. Ferreri

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrés JM Ferreri, MD

Role: STUDY_CHAIR

San Raffaele Scientific Institute, Milano, Italy

Locations

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Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor

Milan, , Italy

Site Status

Countries

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Italy

References

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Ferreri AJM, Sassone M, Miserocchi E, Govi S, Cecchetti C, Corti ME, Mappa S, Arcaini L, Zaja F, Todeschini G, Mannina D, Calimeri T, Perrone S, Ponzoni M, Modorati G. Treatment of MALT lymphoma of the conjunctiva with intralesional rituximab supplemented with autologous serum. Blood Adv. 2020 Mar 24;4(6):1013-1019. doi: 10.1182/bloodadvances.2020001459.

Reference Type DERIVED
PMID: 32182364 (View on PubMed)

Other Identifiers

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IRIS

Identifier Type: -

Identifier Source: org_study_id

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