{ "FullStudy":{ "Rank":217808, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516567", "NCTIdAliasList":{ "NCTIdAlias":[ "NCT01595048" ] }, "OrgStudyIdInfo":{ "OrgStudyId":"Inter B-NHL Ritux 2010 Phase 2" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2010-019224-31", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Gustave Roussy, Cancer Campus, Grand Paris", "OrgClass":"OTHER" }, "BriefTitle":"Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation", "OfficialTitle":"Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL" }, "StatusModule":{ "StatusVerifiedDate":"August 2017", "OverallStatus":"Unknown status", "LastKnownStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 1, 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"April 2019", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 1, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 2, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Gustave Roussy, Cancer Campus, Grand Paris", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Children's Oncology Group", "CollaboratorClass":"NETWORK" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Primary Mediastinal Large B Cell Lymphoma" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"47", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"DA-EPOCH-R", "ArmGroupType":"Experimental", "ArmGroupDescription":"6 courses of Dose Adjusted-EPOCH-Rituximab", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab", "InterventionDescription":"6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "DA-EPOCH-R" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Event free survival", "PrimaryOutcomeDescription":"Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from registration.", "PrimaryOutcomeTimeFrame":"36 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Survival", "SecondaryOutcomeDescription":"Overall survival", "SecondaryOutcomeTimeFrame":"5 years" },{ "SecondaryOutcomeMeasure":"Acute toxicity", "SecondaryOutcomeDescription":"Acute toxicity during treatment according to NCI-CTC V4", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Long term toxicity", "SecondaryOutcomeDescription":"Long term toxicity, especially immune reconstitution, cardiac toxicity", "SecondaryOutcomeTimeFrame":"5 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHistologically proven Primary Mediastinal Large B-Cell Lymphoma (PMLBL).\nPMLBL without central nervous system (CNS) involvement.\n6 months to less than 18 years of age at the time of consent.\nMales and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab\nComplete initial work-up within 8 days prior to treatment that allows definite staging.\nAble to comply with scheduled follow-up and with management of toxicity.\nSigned informed consent from patients and/or their parents or legal guardians\n\nExclusion Criteria:\n\nFollicular lymphoma, mucosa-associated lymphoid tissue (MALT) and nodular marginal zone\nPMLBL patients with CNS involvement\nPatients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.\nEvidence of pregnancy or lactation period.\nThere will be no exclusion criteria based on organ function.\nPast or current anti-cancer treatment except corticosteroids during less than one week.\nTumor cell negative for CD20\nPrior exposure to rituximab.\nSevere active viral infection, especially hepatitis B.\nHepatitis B carrier status history of hepatitis B virus (HBV) or positive serology.\nParticipation in another investigational drug clinical trial.\nPatients who, for any reason, are not able to comply with the national legislation.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"6 Months", "MaximumAge":"17 Years", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Catherine PATTE, MD", "OverallOfficialAffiliation":"Institut Gustave Roussy, Villejuif, FRANCE", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Thomas GROSS, MD", "OverallOfficialAffiliation":"Children's Oncology Group, USA", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University Hospitals Leuven", "LocationCity":"Leuven", "LocationZip":"3000", "LocationCountry":"Belgium" },{ "LocationFacility":"Children Oncology Group Operations centres", "LocationCity":"Monrovia", "LocationCountry":"Canada" },{ "LocationFacility":"Gustave Roussy", "LocationCity":"Villejuif", "LocationZip":"94805", "LocationCountry":"France" },{ "LocationFacility":"2nd Dept. of Pediatrics Semmelweis Univ.", "LocationCity":"Budapest", "LocationZip":"1094", "LocationCountry":"Hungary" },{ "LocationFacility":"Associazione Italiana di Ematologia ed Oncologia Pediatrica", "LocationCity":"Padova", "LocationZip":"35128", "LocationCountry":"Italy" },{ "LocationFacility":"Emma Children's Hospital", "LocationCity":"Amsterdam", "LocationZip":"1105 AZ", "LocationCountry":"Netherlands" },{ "LocationFacility":"Rectorat of Medical University", "LocationCity":"Wroclaw", "LocationCountry":"Poland" },{ "LocationFacility":"Sociedad Española de Hematología y Oncología Pediátricas", "LocationCity":"Valencia", "LocationZip":"46010", "LocationCountry":"Spain" },{ "LocationFacility":"University of Birmingham", "LocationCity":"Birmingham", "LocationCountry":"United Kingdom" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000003520", "InterventionMeshTerm":"Cyclophosphamide" },{ "InterventionMeshId":"D000069283", "InterventionMeshTerm":"Rituximab" },{ "InterventionMeshId":"D000004317", "InterventionMeshTerm":"Doxorubicin" },{ "InterventionMeshId":"D000005047", "InterventionMeshTerm":"Etoposide" },{ "InterventionMeshId":"D000014750", "InterventionMeshTerm":"Vincristine" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000007166", "InterventionAncestorTerm":"Immunosuppressive Agents" },{ "InterventionAncestorId":"D000007155", "InterventionAncestorTerm":"Immunologic Factors" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" },{ "InterventionAncestorId":"D000018906", "InterventionAncestorTerm":"Antineoplastic Agents, Alkylating" },{ "InterventionAncestorId":"D000000477", "InterventionAncestorTerm":"Alkylating Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000019653", "InterventionAncestorTerm":"Myeloablative Agonists" },{ "InterventionAncestorId":"D000074322", "InterventionAncestorTerm":"Antineoplastic Agents, Immunological" },{ "InterventionAncestorId":"D000000903", "InterventionAncestorTerm":"Antibiotics, Antineoplastic" },{ "InterventionAncestorId":"D000059005", "InterventionAncestorTerm":"Topoisomerase II Inhibitors" },{ "InterventionAncestorId":"D000059003", "InterventionAncestorTerm":"Topoisomerase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000000972", "InterventionAncestorTerm":"Antineoplastic Agents, Phytogenic" },{ "InterventionAncestorId":"D000050257", "InterventionAncestorTerm":"Tubulin Modulators" },{ "InterventionAncestorId":"D000050256", "InterventionAncestorTerm":"Antimitotic Agents" },{ "InterventionAncestorId":"D000050258", "InterventionAncestorTerm":"Mitosis Modulators" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M6075", "InterventionBrowseLeafName":"Doxorubicin", "InterventionBrowseLeafAsFound":"Doxorubicin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M235025", "InterventionBrowseLeafName":"Liposomal doxorubicin", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M6774", "InterventionBrowseLeafName":"Etoposide", "InterventionBrowseLeafAsFound":"Etoposide", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M5310", "InterventionBrowseLeafName":"Cyclophosphamide", "InterventionBrowseLeafAsFound":"Cyclophosphamide", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M373", "InterventionBrowseLeafName":"Rituximab", "InterventionBrowseLeafAsFound":"Rituximab", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16078", "InterventionBrowseLeafName":"Vincristine", "InterventionBrowseLeafAsFound":"Vincristine", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M260518", "InterventionBrowseLeafName":"Etoposide phosphate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8795", "InterventionBrowseLeafName":"Immunosuppressive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8784", "InterventionBrowseLeafName":"Immunologic Factors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19188", "InterventionBrowseLeafName":"Antirheumatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2401", "InterventionBrowseLeafName":"Alkylating Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1346", "InterventionBrowseLeafName":"Antineoplastic Agents, Immunological", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2805", "InterventionBrowseLeafName":"Antibiotics, Antitubercular", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24784", "InterventionBrowseLeafName":"Tubulin Modulators", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24783", "InterventionBrowseLeafName":"Antimitotic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008223", "ConditionMeshTerm":"Lymphoma" },{ "ConditionMeshId":"D000016393", "ConditionMeshTerm":"Lymphoma, B-Cell" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000008232", "ConditionAncestorTerm":"Lymphoproliferative Disorders" },{ "ConditionAncestorId":"D000008206", "ConditionAncestorTerm":"Lymphatic Diseases" },{ "ConditionAncestorId":"D000007160", "ConditionAncestorTerm":"Immunoproliferative Disorders" },{ "ConditionAncestorId":"D000007154", "ConditionAncestorTerm":"Immune System Diseases" },{ "ConditionAncestorId":"D000008228", "ConditionAncestorTerm":"Lymphoma, Non-Hodgkin" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9803", "ConditionBrowseLeafName":"Lymphoma", "ConditionBrowseLeafAsFound":"Lymphoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M17411", "ConditionBrowseLeafName":"Lymphoma, B-Cell", "ConditionBrowseLeafAsFound":"B-cell Lymphoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9808", "ConditionBrowseLeafName":"Lymphoproliferative Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9786", "ConditionBrowseLeafName":"Lymphatic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8789", "ConditionBrowseLeafName":"Immunoproliferative Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8783", "ConditionBrowseLeafName":"Immune System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9805", "ConditionBrowseLeafName":"Lymphoma, Non-Hodgkin", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T3556", "ConditionBrowseLeafName":"Lymphosarcoma", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T642", "ConditionBrowseLeafName":"B-cell Lymphoma", "ConditionBrowseLeafAsFound":"B-cell Lymphoma", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC15", "ConditionBrowseBranchName":"Blood and Lymph Conditions" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }