Nctid:
NCT00001586
Payload:
{"FullStudy"=>{"Rank"=>474110, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007938", "ConditionMeshTerm"=>"Leukemia"}, {"ConditionMeshId"=>"D000007945", "ConditionMeshTerm"=>"Leukemia, Lymphoid"}, {"ConditionMeshId"=>"D000015451", "ConditionMeshTerm"=>"Leukemia, Lymphocytic, Chronic, 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", 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Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000069283", "InterventionMeshTerm"=>"Rituximab"}, {"InterventionMeshId"=>"C000024352", "InterventionMeshTerm"=>"Fludarabine"}, {"InterventionMeshId"=>"C000042382", "InterventionMeshTerm"=>"Fludarabine phosphate"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000074322", "InterventionAncestorTerm"=>"Antineoplastic Agents, Immunological"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000018501", "InterventionAncestorTerm"=>"Antirheumatic Agents"}, {"InterventionAncestorId"=>"D000000964", "InterventionAncestorTerm"=>"Antimetabolites, Antineoplastic"}, {"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000007166", "InterventionAncestorTerm"=>"Immunosuppressive Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M283197", "InterventionBrowseLeafName"=>"Fludarabine", "InterventionBrowseLeafAsFound"=>"Surgical", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M373", "InterventionBrowseLeafName"=>"Rituximab", "InterventionBrowseLeafAsFound"=>"Adults", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M225453", "InterventionBrowseLeafName"=>"Fludarabine phosphate", "InterventionBrowseLeafAsFound"=>"Observation", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M1346", "InterventionBrowseLeafName"=>"Antineoplastic Agents, Immunological", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20294", "InterventionBrowseLeafName"=>"Antirheumatic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9902", "InterventionBrowseLeafName"=>"Immunosuppressive Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antirheumatic Agents", "InterventionBrowseBranchAbbrev"=>"ARhu"}]}}}, "ResultsSection"=>{"MoreInfoModule"=>{"PointOfContact"=>{"PointOfContactEMail"=>"wilsonw@mail.nih.gov", "PointOfContactPhone"=>"301-435-2415", "PointOfContactTitle"=>"Wyndham H. Wilson, M.D.", "PointOfContactOrganization"=>"National Cancer Institute, National Institutes of Health"}, "CertainAgreement"=>{"AgreementPISponsorEmployee"=>"No", "AgreementRestrictiveAgreement"=>"No"}}, "AdverseEventsModule"=>{"EventGroupList"=>{"EventGroup"=>[{"EventGroupId"=>"EG000", "EventGroupTitle"=>"Intermediate-high Risk B-Cell Pts", "EventGroupDescription"=>"Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.", "EventGroupOtherNumAtRisk"=>"49", "EventGroupOtherNumAffected"=>"18", "EventGroupSeriousNumAtRisk"=>"49", "EventGroupSeriousNumAffected"=>"19"}, {"EventGroupId"=>"EG001", "EventGroupTitle"=>"Low-Intermediate Risk B-Cell Pts", "EventGroupDescription"=>"Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.", "EventGroupOtherNumAtRisk"=>"0", "EventGroupOtherNumAffected"=>"0", "EventGroupSeriousNumAtRisk"=>"0", "EventGroupSeriousNumAffected"=>"0"}]}, "OtherEventList"=>{"OtherEvent"=>[{"OtherEventTerm"=>"AST, SGOT(serum glutamic oxaloacetic transaminase)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"11", "OtherEventStatsNumAffected"=>"10"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Hepatobiliary disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Rhinorrhea", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"25", "OtherEventStatsNumAffected"=>"15"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Immune system disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Alkaline phosphatase", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"3", "OtherEventStatsNumAffected"=>"3"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Hepatobiliary disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Allergic reaction/hypersensitivity (including drug fever)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"4", "OtherEventStatsNumAffected"=>"3"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Immune system disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"6", "OtherEventStatsNumAffected"=>"5"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Immune system disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Anorexia", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"6", "OtherEventStatsNumAffected"=>"6"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Gastrointestinal disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Autoimmune reaction", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"3", "OtherEventStatsNumAffected"=>"3"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Immune system disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Bilirubin (hyperbilirubinemia)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"6", "OtherEventStatsNumAffected"=>"4"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Hepatobiliary disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Calcium, serum-low (hypocalcemia)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"2", "OtherEventStatsNumAffected"=>"2"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Metabolism and nutrition disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Cardiac arrhythmia - Other, Specify, unknown", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"1", "OtherEventStatsNumAffected"=>"1"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Cardiac disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Confusion", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"1", "OtherEventStatsNumAffected"=>"1"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Psychiatric disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Cough", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"5", "OtherEventStatsNumAffected"=>"4"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Respiratory, thoracic and mediastinal disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Creatinine", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"4", "OtherEventStatsNumAffected"=>"1"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Renal and urinary disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Diarrhea", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"6", "OtherEventStatsNumAffected"=>"5"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Gastrointestinal disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Dizziness", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"5", "OtherEventStatsNumAffected"=>"4"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Nervous system disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Dyspnea (shortness of breath)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"3", "OtherEventStatsNumAffected"=>"3"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Respiratory, thoracic and mediastinal disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Edema: limb", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"1", "OtherEventStatsNumAffected"=>"1"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"General disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Fatigue (asthenia, lethargy, malaise)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"5", "OtherEventStatsNumAffected"=>"5"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"General disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Febrile neutropenia", "OtherEventNotes"=>"(fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"3", "OtherEventStatsNumAffected"=>"3"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Infections and infestations", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"9", "OtherEventStatsNumAffected"=>"8"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"General disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Glucose, serum-low (hyperglycemia)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"17", "OtherEventStatsNumAffected"=>"12"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Metabolism and nutrition disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Glucose, serum-low (hypoglycemia)", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"4", "OtherEventStatsNumAffected"=>"4"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Metabolism and nutrition disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Heartburn/dyspepsia", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"1", "OtherEventStatsNumAffected"=>"1"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Gastrointestinal disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Hemorrhage, GI::Oral cavity", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"1", "OtherEventStatsNumAffected"=>"1"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Blood and lymphatic system disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Hemorrhage, pulmonary/upper respiratory: Nose", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"1", "OtherEventStatsNumAffected"=>"1"}, {"OtherEventStatsGroupId"=>"EG001", "OtherEventStatsNumAtRisk"=>"0", "OtherEventStatsNumEvents"=>"0", "OtherEventStatsNumAffected"=>"0"}]}, "OtherEventOrganSystem"=>"Blood and lymphatic system disorders", "OtherEventAssessmentType"=>"Systematic Assessment", "OtherEventSourceVocabulary"=>"CTCv2.0"}, {"OtherEventTerm"=>"Transfusion", "OtherEventStatsList"=>{"OtherEventStats"=>[{"OtherEventStatsGroupId"=>"EG000", "OtherEventStatsNumAtRisk"=>"49", "OtherEventStatsNumEvents"=>"3", "OtherEventStatsNumAffected"=>"3"}, 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{"SeriousEventTerm"=>"Infection with normal ANC or Grade 1 or 2 neutrophils::External ear (otitis externa)", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", "SeriousEventStatsNumEvents"=>"0", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Infections and infestations", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCv2.0"}, {"SeriousEventTerm"=>"Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", 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"SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", "SeriousEventStatsNumEvents"=>"0", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Infections and infestations", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCv2.0"}, {"SeriousEventTerm"=>"Leukocytes (total WBC)", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"31", "SeriousEventStatsNumAffected"=>"19"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", "SeriousEventStatsNumEvents"=>"0", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Blood and lymphatic system disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCv2.0"}, {"SeriousEventTerm"=>"Lymphopenia", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"36", "SeriousEventStatsNumAffected"=>"18"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", "SeriousEventStatsNumEvents"=>"0", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Blood and lymphatic system disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCv2.0"}, {"SeriousEventTerm"=>"Pain::Neuralgia/peripheral nerve", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", "SeriousEventStatsNumEvents"=>"0", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Nervous system disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCv2.0"}, {"SeriousEventTerm"=>"Platelets", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"2", "SeriousEventStatsNumAffected"=>"2"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", "SeriousEventStatsNumEvents"=>"0", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Blood and lymphatic system disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCv2.0"}, {"SeriousEventTerm"=>"Pleural effusion (non-malignant)", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", "SeriousEventStatsNumEvents"=>"0", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Respiratory, thoracic and mediastinal disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCv2.0"}, {"SeriousEventTerm"=>"Rash/desquamation", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"3", "SeriousEventStatsNumAffected"=>"3"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", "SeriousEventStatsNumEvents"=>"0", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Skin and subcutaneous tissue disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCv2.0"}, {"SeriousEventTerm"=>"Thrombosis/embolism (vascular access-related)", "SeriousEventStatsList"=>{"SeriousEventStats"=>[{"SeriousEventStatsGroupId"=>"EG000", "SeriousEventStatsNumAtRisk"=>"49", "SeriousEventStatsNumEvents"=>"1", "SeriousEventStatsNumAffected"=>"1"}, {"SeriousEventStatsGroupId"=>"EG001", "SeriousEventStatsNumAtRisk"=>"0", "SeriousEventStatsNumEvents"=>"0", "SeriousEventStatsNumAffected"=>"0"}]}, "SeriousEventOrganSystem"=>"Vascular disorders", "SeriousEventAssessmentType"=>"Systematic Assessment", "SeriousEventSourceVocabulary"=>"CTCv2.0"}]}, "EventsDescription"=>"The low-intermediate risk B cell patients did not receive any treatment. No adverse events were collected for these patients. This group does not have adverse events.", "EventsFrequencyThreshold"=>"0"}, "OutcomeMeasuresModule"=>{"OutcomeMeasureList"=>{"OutcomeMeasure"=>[{"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeClassTitle"=>"6 hours post treatment (e.g. ># cells)", "OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"30", "OutcomeMeasurementGroupId"=>"OG000"}]}}]}}, {"OutcomeClassTitle"=>"24 hours post treatment (e.g. > # cells)", "OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"50", "OutcomeMeasurementGroupId"=>"OG000"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"12", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"0", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Intermediate-high Risk B-Cell Pts", "OutcomeGroupDescription"=>"Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Low-Intermediate Risk B-Cell Pts", "OutcomeGroupDescription"=>"Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered."}]}, "OutcomeMeasureType"=>"Primary", "OutcomeMeasureTitle"=>"Change in Gene Expression Post Chemo", "OutcomeMeasureParamType"=>"Number", "OutcomeMeasureTimeFrame"=>"6 hours post treatment, and 24 hours post treatment", "OutcomeMeasureDescription"=>"Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a >50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells.", "OutcomeMeasureUnitOfMeasure"=>"Percent change in cells", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"There were only 12 patients analyzed for various reasons such as timing of treatment, ability to collect samples, and viability of samples."}, {"OutcomeClassList"=>{"OutcomeClass"=>[{"OutcomeCategoryList"=>{"OutcomeCategory"=>[{"OutcomeMeasurementList"=>{"OutcomeMeasurement"=>[{"OutcomeMeasurementValue"=>"18", "OutcomeMeasurementGroupId"=>"OG000"}]}}]}}]}, "OutcomeDenomList"=>{"OutcomeDenom"=>[{"OutcomeDenomUnits"=>"Participants", "OutcomeDenomCountList"=>{"OutcomeDenomCount"=>[{"OutcomeDenomCountValue"=>"49", "OutcomeDenomCountGroupId"=>"OG000"}, {"OutcomeDenomCountValue"=>"0", "OutcomeDenomCountGroupId"=>"OG001"}]}}]}, "OutcomeGroupList"=>{"OutcomeGroup"=>[{"OutcomeGroupId"=>"OG000", "OutcomeGroupTitle"=>"Intermediate-high Risk B-Cell Pts", "OutcomeGroupDescription"=>"Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days."}, {"OutcomeGroupId"=>"OG001", "OutcomeGroupTitle"=>"Low-Intermediate Risk B-Cell Pts", "OutcomeGroupDescription"=>"Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered."}]}, "OutcomeMeasureType"=>"Secondary", "OutcomeMeasureTitle"=>"Number of Participants With Adverse Events", "OutcomeMeasureParamType"=>"Number", "OutcomeMeasureTimeFrame"=>"13 years, 10.5 months", "OutcomeMeasureDescription"=>"Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.", "OutcomeMeasureUnitOfMeasure"=>"Participants", "OutcomeMeasureReportingStatus"=>"Posted", "OutcomeMeasurePopulationDescription"=>"The low-intermediate risk patients received no treatment so their tissue/blood was not analyzed for change."}]}}, "ParticipantFlowModule"=>{"FlowGroupList"=>{"FlowGroup"=>[{"FlowGroupId"=>"FG000", "FlowGroupTitle"=>"Intermediate-high Risk B-Cell Pts", "FlowGroupDescription"=>"Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days."}, {"FlowGroupId"=>"FG001", "FlowGroupTitle"=>"Low-Intermediate Risk B-Cell Pts", "FlowGroupDescription"=>"Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered. Eligible to donate cells."}]}, "FlowPeriodList"=>{"FlowPeriod"=>[{"FlowPeriodTitle"=>"Overall Study", "FlowMilestoneList"=>{"FlowMilestone"=>[{"FlowMilestoneType"=>"STARTED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"49"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"56"}]}}, {"FlowMilestoneType"=>"COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"49"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"56"}]}}, {"FlowMilestoneType"=>"NOT COMPLETED", "FlowAchievementList"=>{"FlowAchievement"=>[{"FlowAchievementGroupId"=>"FG000", "FlowAchievementNumSubjects"=>"0"}, {"FlowAchievementGroupId"=>"FG001", "FlowAchievementNumSubjects"=>"0"}]}}]}}]}}, "BaselineCharacteristicsModule"=>{"BaselineDenomList"=>{"BaselineDenom"=>[{"BaselineDenomUnits"=>"Participants", "BaselineDenomCountList"=>{"BaselineDenomCount"=>[{"BaselineDenomCountValue"=>"49", "BaselineDenomCountGroupId"=>"BG000"}, {"BaselineDenomCountValue"=>"56", "BaselineDenomCountGroupId"=>"BG001"}, {"BaselineDenomCountValue"=>"105", "BaselineDenomCountGroupId"=>"BG002"}]}}]}, "BaselineGroupList"=>{"BaselineGroup"=>[{"BaselineGroupId"=>"BG000", "BaselineGroupTitle"=>"Intermediate-high Risk B-Cell Pts", "BaselineGroupDescription"=>"Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days."}, {"BaselineGroupId"=>"BG001", "BaselineGroupTitle"=>"Low-Intermediate Risk B-Cell Pts", "BaselineGroupDescription"=>"Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered."}, {"BaselineGroupId"=>"BG002", "BaselineGroupTitle"=>"Total", "BaselineGroupDescription"=>"Total of all reporting groups"}]}, "BaselineMeasureList"=>{"BaselineMeasure"=>[{"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"<=18 years", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Between 18 and 65 years", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"39", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"39", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"78", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>">=65 years", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"10", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"17", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"27", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Age, Categorical", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"56.2", "BaselineMeasurementSpread"=>"9.34", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"58.42", "BaselineMeasurementSpread"=>"11.32", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"57.98", "BaselineMeasurementSpread"=>"11.11", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Age Continuous", "BaselineMeasureParamType"=>"Mean", "BaselineMeasureUnitOfMeasure"=>"years", "BaselineMeasureDispersionType"=>"Standard Deviation"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"Female", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"19", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"21", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"40", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Male", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"30", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"35", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"65", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Sex: Female, Male", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"Hispanic or Latino", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Not Hispanic or Latino", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"49", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"55", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"104", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Unknown or Not Reported", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Ethnicity (NIH/OMB)", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineCategoryTitle"=>"American Indian or Alaska Native", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Asian", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"2", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Black or African American", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"6", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"2", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"8", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"White", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"42", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"52", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"94", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"More than one race", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG002"}]}}, {"BaselineCategoryTitle"=>"Unknown or Not Reported", "BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"0", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"1", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Race (NIH/OMB)", "BaselineMeasureParamType"=>"Count of Participants", "BaselineMeasureUnitOfMeasure"=>"Participants"}, {"BaselineClassList"=>{"BaselineClass"=>[{"BaselineClassTitle"=>"United States", "BaselineCategoryList"=>{"BaselineCategory"=>[{"BaselineMeasurementList"=>{"BaselineMeasurement"=>[{"BaselineMeasurementValue"=>"49", "BaselineMeasurementGroupId"=>"BG000"}, {"BaselineMeasurementValue"=>"56", "BaselineMeasurementGroupId"=>"BG001"}, {"BaselineMeasurementValue"=>"105", "BaselineMeasurementGroupId"=>"BG002"}]}}]}}]}, "BaselineMeasureTitle"=>"Region of Enrollment", "BaselineMeasureParamType"=>"Number", "BaselineMeasureUnitOfMeasure"=>"participants"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"105"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 2013", "CompletionDateStruct"=>{"CompletionDate"=>"November 2011", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"March 19, 2013", "StudyFirstSubmitDate"=>"November 3, 1999", "ResultsFirstSubmitDate"=>"December 18, 2012", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"May 15, 2013", "LastUpdatePostDateType"=>"Estimate"}, "ResultsFirstSubmitQCDate"=>"March 19, 2013", "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "ResultsFirstPostDateStruct"=>{"ResultsFirstPostDate"=>"May 15, 2013", "ResultsFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"November 2011", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Change in Gene Expression Post Chemo", "PrimaryOutcomeTimeFrame"=>"6 hours post treatment, and 24 hours post treatment", "PrimaryOutcomeDescription"=>"Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a >50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells."}]}, "SecondaryOutcomeList"=>{"SecondaryOutcome"=>[{"SecondaryOutcomeMeasure"=>"Number of Participants With Adverse Events", "SecondaryOutcomeTimeFrame"=>"13 years, 10.5 months", "SecondaryOutcomeDescription"=>"Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module."}]}}, "OversightModule"=>{"OversightHasDMC"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Genetics", "Bone Marrow Transplantation", "Immunosuppression", "T Lymphocytes", "Marrow Purging"]}, "ConditionList"=>{"Condition"=>["Chronic Lymphocytic Leukemia"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"1139039", "ReferenceType"=>"background", "ReferenceCitation"=>"Rai KR, Sawitsky A, Cronkite EP, Chanana AD, Levy RN, Pasternack BS. Clinical staging of chronic lymphocytic leukemia. Blood. 1975 Aug;46(2):219-34."}, {"ReferencePMID"=>"1699283", "ReferenceType"=>"background", "ReferenceCitation"=>"Keating MJ. Fludarabine phosphate in the treatment of chronic lymphocytic leukemia. Semin Oncol. 1990 Oct;17(5 Suppl 8):49-62."}, {"ReferencePMID"=>"8822923", "ReferenceType"=>"background", "ReferenceCitation"=>"Raife TJ, Demetroulis EM, Lentz SR. Regulation of thrombomodulin expression by all-trans retinoic acid and tumor necrosis factor-alpha: differential responses in keratinocytes and endothelial cells. Blood. 1996 Sep 15;88(6):2043-9."}, {"ReferencePMID"=>"23716541", "ReferenceType"=>"derived", "ReferenceCitation"=>"Mo CC, Njuguna N, Beum PV, Lindorfer MA, Vire B, Lee E, Marti G, Wilson WH, Taylor RP, Wiestner A. Rapid clearance of rituximab may contribute to the continued high incidence of autoimmune hematologic complications of chemoimmunotherapy for chronic lymphocytic leukemia. Haematologica. 2013 Aug;98(8):1259-63. doi: 10.3324/haematol.2012.080929. Epub 2013 May 28."}, {"ReferencePMID"=>"20940416", "ReferenceType"=>"derived", "ReferenceCitation"=>"Herishanu Y, Perez-Galan P, Liu D, Biancotto A, Pittaluga S, Vire B, Gibellini F, Njuguna N, Lee E, Stennett L, Raghavachari N, Liu P, McCoy JP, Raffeld M, Stetler-Stevenson M, Yuan C, Sherry R, Arthur DC, Maric I, White T, Marti GE, Munson P, Wilson WH, Wiestner A. The lymph node microenvironment promotes B-cell receptor signaling, NF-kappaB activation, and tumor proliferation in chronic lymphocytic leukemia. Blood. 2011 Jan 13;117(2):563-74. doi: 10.1182/blood-2010-05-284984. Epub 2010 Oct 12."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"http://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1997-C-0178.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"Background:\n\nCombined therapy with rituximab and fludarabine is the treatment of choice for advanced stage chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).\nA new technology called deoxyribonucleic acid (DNA) microarray can be used to gain knowledge about the genetic basis of CLL/SLL.\nGenetic studies of CLL/SLL may improve our understanding of what happens in the disease, help determine which patients are most likely to respond to treatment with fludarabine and rituximab, and identify new treatments.\n\nObjectives:\n\n-To gain further knowledge about CLL/SLL and the role of rituximab and fludarabine in treating the disease.\n\nEligibility:\n\n-Patients 18 years of age and older with low, intermediate or high-risk CLL/SLL.\n\nDesign:\n\nPatients with low-risk CLL/SLL do not receive treatment, but are followed every 3 to 6 months and donate cells (through apheresis) or lymph nodes, or both, for research purposes.\nPatients with intermediate or high-risk CLL/SLL receive standard treatment with rituximab and fludarabine for six 28-day treatment cycles. Rituximab is given on day 1 and fludarabine is given on days 1-5. (For the first cycle only, fludarabine treatment starts on day 2. This delay permits blood sampling on day 1 for the effect of rituximab on white blood cells.)\nLaboratory tests and imaging studies are done periodically to monitor drug side effects and the response to treatment. Tests include bone marrow biopsy and aspiration, blood tests and x-rays, including positron emission tomography (PET) and computed tomography (CT) scans.", "DetailedDescription"=>"Background:\n\nDue to their synergistic action and non-overlapping toxicity profiles, the combination of Rituximab and Fludarabine is the treatment of choice for advanced stage chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL).\nAs such, we have designed this protocol to better understand the genetic basis of CLL/SLL, to identify predictors of treatment response and to study the molecular effects of Rituximab Fludarabine on the leukemic cells.\nA new technology utilizing complementary deoxyribonucleic acid (cDNA) microarrays now permits the simultaneous quantitation of the expression of thousands of genes; this methodology can evaluate defined cellular pathways, and also discover novel genes influencing cell biology.\nIn addition to improving our understanding of the pathogenesis of CLL/SLL, these molecular studies may identify new therapeutic targets in CLL/SLL, and may help to identify those CLL/SLL patients most likely to respond to the combination of Fludarabine and Rituximab.\n\nObjectives:\n\nEvaluate CLL/SLL patients during and following Rituximab Fludarabine chemotherapy for changes in lymphocyte gene expression using DNA microarray analysis.\nEvaluate gene expression by DNA microarray analysis of leukemic cells in blood, bone marrow and lymph nodes.\n\nEligibility:\n\nLow, Intermediate or High-Risk Category of CLL/SLL, using the Modified Three- Stage Rai Staging System\nAge greater than or equal to 18 years.\nPatients must have received no previous cytotoxic or monoclonal antibody therapy.\nEastern Cooperative Oncology Group (ECOG) performance status of 0-2.\nPatients must not be pregnant or breast-feeding.\nPatients with active autoimmune hemolytic anemia (AIHA)) grade III or higher (transfusion or steroids indicated) or immune thrombocytopenia (ITP) grade III or higher (platelets less than 50,000/microL) shall not be enrolled.\nAny patient with a medical condition that requires chronic use of corticosteroids shall not be enrolled.\n\nDesign:\n\nPatients who do not require treatment will be followed every 3-6 months and will donate cellular products, bone marrow biopsies, bone marrow aspirates and/or lymph nodes for research purposes.\nPatients who do require treatment will received the standard dose of the Rituximab monoclonal antibody and the standard dose of Fludarabine for a total of six cycles. In the first cycle, Rituximab will be given on day 1 with Fludarabine being given on days 2-6. This will allow for appropriate samplings of the effects of Rituximab on lymphocytes before during and at the end of the first 24 hours. In subsequent cycles 2-6, the Rituximab and day 1 Fludarabine can both be given on day 1."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nDiagnosis of chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) will be made according to the World Health Organization (WHO) diagnostic classification. A lymphocyte count in excess of 5000/mcl is typically found in the leukemic variant but is not a pre-requisite for a diagnosis of SLL. Low, Intermediate or High-Risk Category of CLL/SLL, using the Modified Three-Stage Rai Staging System as follows:\n\nRisk Category: Low Risk\n\nRai Stage: 0\n\nClinical Features: Elevated blood and marrow lymphocyte numbers only (L). (lymphocytes greater than 5000/microl in blood, and lymphocytes greater than 30 percent in marrow).\n\nRisk Category: Intermediate Risk\n\nRai Stage: I\n\nClinical Features: L + enlarged lymph nodes (LN)\n\nRisk Category: Intermediate Risk\n\nRai Stage: II\n\nClinical Features: L + enlarged spleen or liver\n\nRisk Category: High Risk\n\nRai Stage: III\n\nClinical Features: L + anemia (Hemoglobin less than 11 gm/dl)\n\nRisk Category: High Risk\n\nRai Stage: IV\n\nClinical Features: L + thrombocytopenia (platelets less than 100,000/microl)\n\nPatients in the modified Rai high risk group and select patients in the intermediate risk group will undergo treatment with Rituximab Fludarabine. To meet treatment criteria patients in the intermediate risk group should have evidence of active disease as demonstrated by at least one of the following criteria:\n\nmassive or progressive splenomegaly or lymphadenopathy;\npresence of weight loss greater than 10% over the preceding 6 months;\nconstitutional symptoms of extreme fatigue, night sweats or recurrent fever of greater than 100 degrees F (documented fevers must be occurring without evidence of specific infection), and bone pain;\nprogressive lymphocytosis with an increase of greater than 50% over a 2 month period, or an anticipated doubling time of less than 6 months;\nchronic infections either increased number or prolonged infections;\nother high risk prognostic indicators such as excess elevation of beta-2-microglobulin, cluster differentiation 38 (CD38) expression and adverse cytogenetics may be used to better appraise the risk in each individual patient.\n\nPatients with a diagnosis of CLL/SLL who do not meet the eligibility criteria for receiving Rituximab and Fludarabine (are not intermediate- or high-risk CLL/SLL), can enroll on the protocol for the purpose of donating cellular products. Such patients will not receive rituximab and fludarabine chemotherapy. At a later date, if it is documented that the patient does meet the criteria, then the patient may receive Rituximab and Fludarabine (after discussion with the Principal Investigator).\n\nIn a limited number of cases, patients with low-risk CLL/SLL may be initiated on Rituximab and Fludarabine treatment. For example, individuals who are candidates for bone marrow transplantation may be started on Rituximab Fludarabine as an induction regimen prior to transplantation. Additionally, some low-risk patients may be started on Rituximab and Fludarabine for psychological reasons (patient insistence on starting chemotherapy prior to disease progression). However, it must be stressed that low-risk CLL/SLL patients will be discouraged from initiating therapy except in these specific cases.\n\nAge greater than or equal to 18 years of age.\n\nPatients must have received no prior cytotoxic or monoclonal antibody therapy.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n\nRequired initial laboratory tests: Blood urea nitrogen (BUN) and Creatinine values must be less than or equal to 1.5 times the normal values; alternatively, patients with creatinine clearance of greater than 50 ml per minute will also be eligible. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values must be less than or equal to 2.0 times normal values; patients with laboratory values greater than these levels may be enrolled on the protocol (after a specific approval from the Principal Investigator) if the values are due to a known, pre-existing liver disease. Bilirubin must be less than or equal to 2.0 mg/dl unless due to Gilbert's disease.\n\nThe patient must be competent to sign an informed consent, and sign the protocol consent form.\n\nEXCLUSION CRITERIA:\n\nPatients must not be pregnant or breastfeeding.\n\nPatients with active autoimmune hemolytic anemia (AIHA)) grade III or higher (transfusion or steroids indicated) or immune thrombocytopenia (ITP) grade III or higher (platelets less than 50,000/microL) shall not be enrolled. Patients with a history of prior therapy to control either AIHA or ITP will be eligible, provided they do not require maintenance corticosteroids, and have not received monoclonal antibody therapy in the past 6 months. Patients developing AIHA or ITP on protocol may be managed as medically indicated on protocol but will generally not undergo fludarabine/rituximab treatment until resolution of hemolysis or thrombocytopenia to less than grade III.\n\nAny patient with a medical condition that requires chronic use of corticosteroids shall not be enrolled."}, "IdentificationModule"=>{"NCTId"=>"NCT00001586", "BriefTitle"=>"Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis", "NCTIdAliasList"=>{"NCTIdAlias"=>["NCT00019370"]}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"970178"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-C-0178"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Low-Intermediate Risk B-Cell Pts", "ArmGroupDescription"=>"Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered. Eligible to donate cells.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Other: Leukemic or stroma cells"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Intermediate-high Risk B-Cell Pts", "ArmGroupDescription"=>"Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Biological: Rituximab", "Drug: Fludarabine phosphate"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Rituximab", "InterventionType"=>"Biological", "InterventionDescription"=>"Rituxan", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Rituximab 375 mg/m^2 by infusion on day 1, cycle 1. Repeated every 28 days."]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Intermediate-high Risk B-Cell Pts"]}}, {"InterventionName"=>"Fludarabine phosphate", "InterventionType"=>"Drug", "InterventionDescription"=>"Fludara", "InterventionOtherNameList"=>{"InterventionOtherName"=>["Fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days."]}, "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Intermediate-high Risk B-Cell Pts"]}}, {"InterventionName"=>"Leukemic or stroma cells", "InterventionType"=>"Other", "InterventionDescription"=>"Patients are eligible to donate cells for the purpose of analyzing leukemic cells. Cells can be donated by apheresis (e.g. 60-90 minute intravenous technique), lymph node biopsy (e.g. 3 biopsy/excision of lymph nodes)bone marrow biopsy (e.g. 2-4 separate bone marrow biopsies), and bone marrow aspiration (e.g. 3 to 5cc of marrow per aspirate).", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Low-Intermediate Risk B-Cell Pts"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Wyndham H Wilson, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Cancer Institute, National Institutes of Health"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Cancer Institute (NCI)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"Principal investigator", "ResponsiblePartyInvestigatorFullName"=>"Wyndham Wilson, M.D.", "ResponsiblePartyInvestigatorAffiliation"=>"National Institutes of Health Clinical Center (CC)"}}}}}}