Clinical trial · Interventional
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
NCT01514344CI-TRIAL-00060089IRIScompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma | Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intralesional rituximab | Drug | — | UNRESOLVED |
| supplemental autologous serum | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intralesional rituximab
- interventionNames
- Drug: intralesional rituximab
- Biological: supplemental autologous serum
Primary outcomes (1)
- measure
- assessment of safety
- timeFrame
- During experimental treatment (within 7 months from trial registration)
- description
- assessment of safety of intralesional rituximab in terms of incidence of \>/= G4 adverse events during the experimental treatment
Secondary outcomes (1)
- measure
- assessment of activity
- timeFrame
- at the end of experimental treatment (at 7th month from trial registration)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFerreri 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. PMID 32182364