Evaluation of intraconjuntival treatment with Rituximab in patients affected by NH lymphoma of conjunctiva.

Phase II study on activity and tolerability of intralesional rituximab in relapsed or refractory patients affected by indolentCD-20 positive lymphoma of conjuntiva; evaluation of activity of adding autologous serum in non-responding patients to ritiximab alone.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004908-37-IT

Enrollment

Registered

2011-12-28

Start date

2011-10-21

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

indolent CD-20 positive lymphoma of conjunctiva MedDRA version: 14.1 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: MABTHERA*EV 2F 10ML 100MG Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg/ml milligram(s)/millilitr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Histological diagnosis of CD20 + B-cell lymphoma subtypes: marginal zone lymphoma, follicular lymphoma grade 1-2, linfoplasmocitico lymphoma, small cell lymphoma-location only conjunctival (stage IEA, unilateral or bilateral). -at least one lesion measurable / configurable. -age > or equal 18 years-ECOG-PS =65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: -Conventional cancer treatments (chemotherapy, radiotherapy, immunotherapy), experimental (antibiotics) or concomitant corticosteroid. -Allergy-Systemic symptoms known to rituximab -Pregnancy or nursing being -Co-diagnosis of pemphigus -Postsurgical conjunctival scarring that may interfere with the administration and evaluation of treatment response (second clinical opinion of a specialist eye doctor) -Diagnosis of other cancers malignancy in the previous 5 years (except basal cell skin squamous cell carcinomas in situ of the skin or cervix)-Presence of any physical or psychological that constraints the patient compliance

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate the safety of intralesional rituximab in patients with CD20 + indolent lymphomas of the conjunctiva;Secondary Objective: -to assess the activity of intralesional rituximab in the treatment of CD20 + indolent lymphomas of the conjunctiva in terms of response and duration of response. -to evaluate the clinical impact of adding rituximab to autologous serum in terms of clinical response in patients unresponsive to intralesional rituximab alone.;Primary end point(s): safety of intralesional rituximab, defined by the incidence of adverse events can > or equal to 4 (NCI CTCAE V.4.3) during the experimental treatment.;Timepoint(s) of evaluation of this end point: during treatment and during the entire follow-up	—

Measure

Time frame

Main Objective: to evaluate the safety of intralesional rituximab in patients with CD20 + indolent lymphomas of the conjunctiva;Secondary Objective: -to assess the activity of intralesional rituximab in the treatment of CD20 + indolent lymphomas of the conjunctiva in terms of response and duration of response. -to evaluate the clinical impact of adding rituximab to autologous serum in terms of clinical response in patients unresponsive to intralesional rituximab alone.;Primary end point(s): safety of intralesional rituximab, defined by the incidence of adverse events can > or equal to 4 (NCI CTCAE V.4.3) during the experimental treatment.;Timepoint(s) of evaluation of this end point: during treatment and during the entire follow-up

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Secondary

Measure	Time frame
Secondary end point(s): -Activities of intralesional rituximab (overall response, complete response and duration of response). -Activities of intralesional rituximab in patients with indolent CD20 + conjunctival refractory to previous treatment with systemic rituximab. -Response rate and duration of response with the addition of rituximab to autologous serum in patients unresponsive to rituximab alone.;Timepoint(s) of evaluation of this end point: from the start of the study until the eventual progression	—

Measure

Time frame

Secondary end point(s): -Activities of intralesional rituximab (overall response, complete response and duration of response). -Activities of intralesional rituximab in patients with indolent CD20 + conjunctival refractory to previous treatment with systemic rituximab. -Response rate and duration of response with the addition of rituximab to autologous serum in patients unresponsive to rituximab alone.;Timepoint(s) of evaluation of this end point: from the start of the study until the eventual progression

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Countries

Italy

Contacts

Public ContactUnita' Linfomi

Fondazione San Raffaele del Monte Tabor

ferreri.andres@hsr.it02-26437649

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026