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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intralesional rituximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| assessment of safety | assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment | During experimental treatment (within 7 months from trial registration) |
| Measure | Description | Time Frame |
|---|---|---|
| assessment of activity | assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response | at the end of experimental treatment (at 7th month from trial registration) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrés JM Ferreri, MD | San Raffaele Scientific Institute, Milano, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor | Milan | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32182364 | Derived | 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. |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003165 | Complement System Proteins |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| 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 |
|
|
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |