{ "FullStudy":{ "Rank":217807, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516580", "OrgStudyIdInfo":{ "OrgStudyId":"Inter B-NHL Ritux 2010 Phase 3" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2010-019224-31", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Gustave Roussy, Cancer Campus, Grand Paris", "OrgClass":"OTHER" }, "BriefTitle":"Intergroup Randomized Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Rituximab Evaluation in High Risk Patients", "OfficialTitle":"Intergroup Trial for Children or Adolescents With B-Cell Non Hodgkin Lymphoma or B-Acute Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase III Trial" }, "StatusModule":{ "StatusVerifiedDate":"June 2017", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 13, 2017", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2021", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 13, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 14, 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":"The aim of the trial is to test whether adding 6 injections of rituximab to standard \"Lymphome malin B\" LMB chemotherapy regimen improves the Event Free Survival (EFS) compared with LMB chemotherapy alone in children / adolescents with advanced stage B-cell Non-Hodgkin Lymphoma (NHL) / B-Acute Leukemia (B-AL)(stage III and LDH > Nx2, any stage IV or B-AL)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "B-cell Non Hodgkin Lymphoma", "Mature B-cell Leukemia Burkitt-type" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"482", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"LMB chemo", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Prephase (COP) for all groups followed by:\n\nin group B: 4 courses: 2 COPADM + 2 CYM, with MTX 3g/m²\nin group C: 6 courses: 2 COPADM + 2 CYVE + 2 maintenance courses, with MTX 8g/m², in 4h in C1, in 24h in C3 (except the 1st course) and CNS positive patients receive additional IT before each CYVE courses and HDMTX between CYVE courses.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C" ] } },{ "ArmGroupLabel":"LMB chemo + Rituximab", "ArmGroupType":"Experimental", "ArmGroupDescription":"LMB chemo as in the comparator arm Rituximab 375 mg/m² i.v.: 6 injections: two doses at 48h interval are given at D-2 and D1 of the 2 first courses (COPADM) and one dose at the beginning of the 2 following courses (CYM or CYVE).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Rituximab, Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C", "InterventionDescription":"Prephase (COP) for all groups followed by:\n\nin group B: 4 courses: 2 COPADM + 2 CYM, with MTX 3g/m² in group C: 6 courses: 2 COPADM + 2 CYVE + 2 maintenance courses, with MTX 8g/m², in 4h in C1, in 24h in C3 (except the 1st course) and CNS positive patients receive additional IT before each CYVE courses and HDMTX between CYVE courses.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "LMB chemo" ] } },{ "InterventionType":"Drug", "InterventionName":"Rituximab, Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C", "InterventionDescription":"LMB chemo as in the comparator arm Rituximab 375 mg/m² i.v.: 6 injections: two doses at 48h interval are given at D-2 and D1 of the 2 first courses (COPADM) and one dose at the beginning of the 2 following courses (CYM or CYVE).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "LMB chemo + Rituximab" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Event free survival", "PrimaryOutcomeDescription":"Minimum time to death from any cause, presence of viable cells in residue after [2nd (Rituximab-)CYVE], relapse, progressive disease, or second malignancy measured from randomization.", "PrimaryOutcomeTimeFrame":"24 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 or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable.\nStage III with elevated LDH level (\"B-high\"), [LDH > twice the institutional upper limit of the adult normal values (> Nx2)] or any stage IV or B-AL.\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 and during five months for men, taking into account the characteristics of methotrexate.\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, MALT and nodular marginal zone are not included into this therapeutic study\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 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":"Véronique MINARD, MD", "OverallOfficialAffiliation":"Institut Gustave Roussy, Villejuif, FRANCE", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Thomas GROSS, MD", "OverallOfficialAffiliation":"Children 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":"The University of Hong Kong (Clinical Trials Centre)", "LocationCity":"Hong-Kong", "LocationCountry":"China" },{ "LocationFacility":"Institut de Cancérologie 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":"D000003561", 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"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":"D000000020", "InterventionAncestorTerm":"Abortifacient Agents, Nonsteroidal" },{ "InterventionAncestorId":"D000000019", "InterventionAncestorTerm":"Abortifacient Agents" },{ "InterventionAncestorId":"D000012102", "InterventionAncestorTerm":"Reproductive Control Agents" },{ "InterventionAncestorId":"D000000964", "InterventionAncestorTerm":"Antimetabolites, Antineoplastic" },{ "InterventionAncestorId":"D000000963", "InterventionAncestorTerm":"Antimetabolites" },{ "InterventionAncestorId":"D000003879", "InterventionAncestorTerm":"Dermatologic Agents" },{ "InterventionAncestorId":"D000005493", "InterventionAncestorTerm":"Folic Acid Antagonists" },{ "InterventionAncestorId":"D000019384", "InterventionAncestorTerm":"Nucleic Acid Synthesis Inhibitors" },{ "InterventionAncestorId":"D000000998", "InterventionAncestorTerm":"Antiviral Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "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", "InterventionBrowseLeafAsFound":"Doxorubicin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M10286", "InterventionBrowseLeafName":"Methotrexate", "InterventionBrowseLeafAsFound":"Methotrexate", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M5349", 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"InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16129", "InterventionBrowseLeafName":"Vitamin B Complex", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7202", "InterventionBrowseLeafName":"Folic Acid Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2895", "InterventionBrowseLeafName":"Antiviral Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24784", "InterventionBrowseLeafName":"Tubulin Modulators", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M24783", "InterventionBrowseLeafName":"Antimitotic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T446", "InterventionBrowseLeafName":"Folic Acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T447", "InterventionBrowseLeafName":"Folinic Acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T448", "InterventionBrowseLeafName":"Folate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T475", "InterventionBrowseLeafName":"Vitamin B9", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"Derm", "InterventionBrowseBranchName":"Dermatologic Agents" },{ "InterventionBrowseBranchAbbrev":"Repr", "InterventionBrowseBranchName":"Reproductive Control Agents" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" },{ "InterventionBrowseBranchAbbrev":"Hemat", "InterventionBrowseBranchName":"Hematinics" },{ "InterventionBrowseBranchAbbrev":"Vi", "InterventionBrowseBranchName":"Vitamins" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008223", "ConditionMeshTerm":"Lymphoma" },{ "ConditionMeshId":"D000007938", "ConditionMeshTerm":"Leukemia" },{ "ConditionMeshId":"D000008228", "ConditionMeshTerm":"Lymphoma, Non-Hodgkin" },{ "ConditionMeshId":"D000016393", "ConditionMeshTerm":"Lymphoma, B-Cell" },{ "ConditionMeshId":"D000015448", "ConditionMeshTerm":"Leukemia, B-Cell" },{ "ConditionMeshId":"D000015451", "ConditionMeshTerm":"Leukemia, Lymphocytic, Chronic, B-Cell" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", 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"ConditionBrowseLeafAsFound":"B-Cell Non-Hodgkin Lymphoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9528", "ConditionBrowseLeafName":"Leukemia", "ConditionBrowseLeafAsFound":"Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M16698", "ConditionBrowseLeafName":"Leukemia, B-Cell", "ConditionBrowseLeafAsFound":"B Cell Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9805", "ConditionBrowseLeafName":"Lymphoma, Non-Hodgkin", "ConditionBrowseLeafAsFound":"Non-Hodgkin's 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":"M9534", "ConditionBrowseLeafName":"Leukemia, Lymphoid", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T3556", "ConditionBrowseLeafName":"Lymphosarcoma", "ConditionBrowseLeafAsFound":"Lymphoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T1315", "ConditionBrowseLeafName":"Chronic Lymphocytic Leukemia", "ConditionBrowseLeafAsFound":"B Cell Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T642", "ConditionBrowseLeafName":"B-cell Lymphoma", "ConditionBrowseLeafAsFound":"B-Cell Non-Hodgkin 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" } ] } } } } } }