{ "FullStudy":{ "Rank":218033, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513603", "OrgStudyIdInfo":{ "OrgStudyId":"L-10,442" }, "Organization":{ "OrgFullName":"New York Medical College", "OrgClass":"OTHER" }, "BriefTitle":"Trial of Cladribine, Cytarabine, Mitoxantrone, Filgrastim (CLAG-M) in Relapsed Acute Lymphoblastic Leukemia", "OfficialTitle":"Phase II Trial of CLAG-M in Relapsed ALL" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2014", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"January 2014", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 19, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 20, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Karen Seiter", "ResponsiblePartyInvestigatorTitle":"Professor of Medicine", "ResponsiblePartyInvestigatorAffiliation":"New York Medical College" }, "LeadSponsor":{ "LeadSponsorName":"New York Medical College", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"CLAG-M is an active, well tolerated regimen in acute myelogenous leukemia. Each of the agents is active in Acute Lymphoblastic Leukemia (ALL) as well. The current trial will determine the efficacy of the regimen in patients with relapsed ALL.", "DetailedDescription":"Patients will receive standard dose CLAG-M (cladribine, cytarabine, mitoxantrone, filgrastim). Standard support care will be given. Efficacy will be assessed through bone marrow examinations and blood tests." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Acute Lymphoblastic Leukemia", "Lymphoblastic Lymphoma", "Burkitts Leukemia/Lymphoma", "Chronic Myelogenous Leukemia" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"50", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"CLAG-M", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: CLAG-M" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"CLAG-M", "InterventionDescription":"IV times 5 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "CLAG-M" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Leustatin", "Ara-C", "Novantrone" ] } },{ "InterventionType":"Drug", "InterventionName":"CLAG-M", "InterventionDescription":"Chemotherapy", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "CLAG-M" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Cladribine (Leustatin)", "Cytarabine (Ara-c)", "Mitoxantrone (Novantrone)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Complete remission percentage", "PrimaryOutcomeTimeFrame":"1 month" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Survival", "SecondaryOutcomeTimeFrame":"2 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nRelapsed or refractory acute lymphoblastic leukemia,\nBurkitts leukemia/lymphoma,\nLymphoid blastic CML,\nLymphoblastic lymphoma.", "HealthyVolunteers":"No", "Gender":"All", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Karen Seiter, MD", "CentralContactRole":"Contact", "CentralContactPhone":"914 493 7514", "CentralContactEMail":"karen_seiter@nymc.edu" },{ "CentralContactName":"Nasir Ahmed, MD", "CentralContactRole":"Contact", "CentralContactPhone":"914 493 7514", "CentralContactEMail":"nasir_ahmed@nymc.edu" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Karen Seiter, MD", "OverallOfficialAffiliation":"New York Medical College", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Westchester Medical Center/New York Medical College", "LocationStatus":"Recruiting", "LocationCity":"Valhalla", "LocationState":"New York", "LocationZip":"10595", "LocationCountry":"United States", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Karen Seiter, MD", 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