Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma
NCT ID: NCT01514344
Last Updated: 2022-08-04
Study Results
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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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2011-12-31
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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intralesional rituximab
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
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
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* known allergy to rituximab
* systemic symptoms
* concurrent diagnosis of pemphigus
* postsurgical conjunctival scars
18 Years
ALL
No
Sponsors
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Andres J. M. Ferreri
OTHER
Responsible Party
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Andres J. M. Ferreri
MD
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
Countries
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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.
Other Identifiers
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IRIS
Identifier Type: -
Identifier Source: org_study_id
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