{ "FullStudy":{ "Rank":217978, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514344", "OrgStudyIdInfo":{ "OrgStudyId":"IRIS" }, "Organization":{ "OrgFullName":"IRCCS San Raffaele", "OrgClass":"OTHER" }, "BriefTitle":"Intralesional Rituximab for the Treatment of Conjunctival Indolent Lymphoma", "OfficialTitle":"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", "Acronym":"IRIS" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2014", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"October 2015", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 6, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 17, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 23, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Andres J. M. Ferreri", "ResponsiblePartyInvestigatorTitle":"MD", "ResponsiblePartyInvestigatorAffiliation":"IRCCS San Raffaele" }, "LeadSponsor":{ "LeadSponsorName":"Andres J. M. Ferreri", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Phase II, monocentric, open label study to assess safety and activity of intralesional Rituximab for the treatment of indolent CD20+ lymphoma of conjunctiva.", "DetailedDescription":"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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Ocular Adnexal Mucosa-Associated Lymphoid Tissue Lymphoma" ] }, "KeywordList":{ "Keyword":[ "OAL", "MALT", "conjunctiva", "indolent", "CD20+" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"20", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"intralesional rituximab", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: intralesional rituximab", "Biological: supplemental autologous serum" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"intralesional rituximab", "InterventionDescription":"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", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "intralesional rituximab" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Intraconjunctival rituximab; mabthera, anti-CD20 therapy" ] } },{ "InterventionType":"Biological", "InterventionName":"supplemental autologous serum", "InterventionDescription":"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", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "intralesional rituximab" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "autologous serum supplementation; complement" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"assessment of safety", "PrimaryOutcomeDescription":"assessment of safety of intralesional rituximab in terms of incidence of >/= G4 adverse events during the experimental treatment", "PrimaryOutcomeTimeFrame":"During experimental treatment (within 7 months from trial registration)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"assessment of activity", "SecondaryOutcomeDescription":"assessment of activity of intralesional rituximab in terms of overall partial and complete response and duration of response", "SecondaryOutcomeTimeFrame":"at the end of experimental treatment (at 7th month from trial registration)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nhistological diagnosis of CD20+ B cell lymphoma subtypes: marginal zone lymphoma, grade 1-2 follicular lymphoma, plasmocytic lymphoma, small lymphocyte lymphoma\nconjunctival localization alone (1EA stage; mono- or bilateral)\nat least one measurable lesion\nage >/= 18 years\nECOG-PS