{
  "FullStudy":{
    "Rank":218213,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511263",
          "OrgStudyIdInfo":{
            "OrgStudyId":"AC-006-IT"
          },
          "Organization":{
            "OrgFullName":"IRCCS Policlinico S. Matteo",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Epigallocatechingallate (EGCG) in Cardiac AL Amyloidosis",
          "OfficialTitle":"A Phase II Open-label Randomized Study of Dietary Supplement With Epigallocatechin Gallate (EGCG) to Improve Cardiac Dysfunction in Patients With AL Amyloidosis Who do Not Require Chemotherapy (EpiCardiAL)",
          "Acronym":"EpiCardiAL"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2018",
          "OverallStatus":"Terminated",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2016",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2016",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 10, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 20, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 21, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Giampaolo Merlini",
            "ResponsiblePartyInvestigatorTitle":"Director, Amyloidosis Research and Treatment Center",
            "ResponsiblePartyInvestigatorAffiliation":"IRCCS Policlinico S. Matteo"
          },
          "LeadSponsor":{
            "LeadSponsorName":"IRCCS Policlinico S. Matteo",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"In a proportion of patients with AL amyloidosis there is no improvement of cardiac function despite hematologic response to treatment. The aim of the study is to assess whether treatment with EGCG increases the rate of cardiac response in patients with AL amyloidosis who completed chemotherapy.",
          "DetailedDescription":"This will be a phase II open-label randomized trial. Patients with AL amyloidosis and cardiac involvement who have achieved at least partial hematologic response after chemotherapy will be randomized to receive standard supportive therapy (SST) or SST plus Epigallocatechin gallate (EGCG). After giving written informed consent, the patients will be evaluated for eligibility. Briefly, the subjects with a biopsy-proven diagnosis of AL amyloidosis who achieved at least partial response after chemotherapy, who are not planned to receive further chemotherapy and who have significant cardiac dysfunction will be considered eligible. The patients will be stratified according to the quality of hematologic response and to the severity of cardiac involvement. Following stratification, the patients will be randomized to receive SST or SST plus EGCG. The study comprises 3 periods: screening (including stratification and randomization), treatment (with evaluations of response every 2 months) followed by the end-of-treatment evaluation and follow-up. Therapy will continue for up to 1 year. After treatment patients will be followed for 3 years."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Primary Amyloidosis of Light Chain Type"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Epigallocatechin gallate",
              "AL amyloidosis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"86",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Arm A",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"The patients will be divided into 4 strata according to cardiac dysfunction and to the quality of hematologic response. After stratification the patients will be randomized (1:1) within each stratum to receive Standard Therapy alone (Arm A) or Standard Therapy plus Investigational Drug (Arm B).",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias)"
                  ]
                }
              },{
                "ArmGroupLabel":"Arm B",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"The patients will be divided into 4 strata according to cardiac dysfunction and to the quality of hematologic response. After stratification the patients will be randomized (1:1) within each stratum to receive Standard Therapy alone (Arm A) or Standard Therapy plus Investigational Drug (Arm B)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCG"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias)",
                "InterventionDescription":"Antiarrhythmic drugs (i.e. amiodarone), angiotensins which transform inhibitor enzymes, and/or beta-blockers if tolerated.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm A"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCG",
                "InterventionDescription":"Antiarrhythmic drugs (i.e. amiodarone), angiotensins which transform inhibitor enzymes, and/or beta-blockers if tolerated.\n\nEGCG, 675 mg/day, oral, for one year.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm B"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Cardiac response",
                "PrimaryOutcomeDescription":"The primary objective is to assess whether treatment with EGCG increases the rate of cardiac response following chemotherapy in patients with AL amyloidosis. The primary endpoint is cardiac response at 6 months.",
                "PrimaryOutcomeTimeFrame":"6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Rate of adverse events",
                "SecondaryOutcomeDescription":"The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Rate of cardiac progression",
                "SecondaryOutcomeDescription":"The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Time to cardiac progression",
                "SecondaryOutcomeDescription":"The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Rate of cardiac events",
                "SecondaryOutcomeDescription":"The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Time to cardiac events",
                "SecondaryOutcomeDescription":"The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Survival",
                "SecondaryOutcomeDescription":"The secondary objectives are to assess the safety of EGCG in cardiac AL amyloidosis, to determine whether EGCG can prevent or delay cardiac progression and to compare survival of patients receiving EGCG compared to subjects receiving SST.",
                "SecondaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosis of AL amyloidosis.\nAge ≥18 years.\nThe patients must have been treated for AL amyloidosis attaining hematologic response.\nEvidence of cardiac involvement at echocardiography (mean left ventricular wall thickness >12 mm in the absence of other causes).\nNT-proBNP ≥650 ng/L\n\nExclusion Criteria:\n\nNon-AL (e.g. familial, senile) amyloidosis.\nConcomitant non-amyloid related clinically significant cardiac diseases.\nNeed of further chemotherapy for AL amyloidosis.\nEstimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m2.\nUncontrolled infection.\nInability to give informed consent.\nPrevious or ongoing psychiatric illness (excluding reactive depression).\nPregnant or nursing women.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico S.Matteo",
                "LocationCity":"Pavia",
                "LocationZip":"27100",
                "LocationCountry":"Italy"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"15365071",
                "ReferenceType":"background",
                "ReferenceCitation":"Dispenzieri A, Gertz MA, Kyle RA, Lacy MQ, Burritt MF, Therneau TM, Greipp PR, Witzig TE, Lust JA, Rajkumar SV, Fonseca R, Zeldenrust SR, McGregor CG, Jaffe AS. Serum cardiac troponins and N-terminal pro-brain natriuretic peptide: a staging system for primary systemic amyloidosis. J Clin Oncol. 2004 Sep 15;22(18):3751-7."
              },{
                "ReferencePMID":"17785589",
                "ReferenceType":"background",
                "ReferenceCitation":"Hunstein W. Epigallocathechin-3-gallate in AL amyloidosis: a new therapeutic option? Blood. 2007 Sep 15;110(6):2216."
              },{
                "ReferencePMID":"20221615",
                "ReferenceType":"background",
                "ReferenceCitation":"Mereles D, Buss SJ, Hardt SE, Hunstein W, Katus HA. Effects of the main green tea polyphenol epigallocatechin-3-gallate on cardiac involvement in patients with AL amyloidosis. Clin Res Cardiol. 2010 Aug;99(8):483-90. doi: 10.1007/s00392-010-0142-x. Epub 2010 Mar 10."
              },{
                "ReferencePMID":"18317666",
                "ReferenceType":"background",
                "ReferenceCitation":"Mereles D, Wanker EE, Katus HA. Therapy effects of green tea in a patient with systemic light-chain amyloidosis. Clin Res Cardiol. 2008 May;97(5):341-4. doi: 10.1007/s00392-008-0649-6. Epub 2008 Mar 3."
              },{
                "ReferencePMID":"18519408",
                "ReferenceType":"background",
                "ReferenceCitation":"Merlini G, Palladini G. Amyloidosis: is a cure possible? Ann Oncol. 2008 Jun;19 Suppl 4:iv63-6. doi: 10.1093/annonc/mdn200. Review."
              },{
                "ReferencePMID":"20644111",
                "ReferenceType":"background",
                "ReferenceCitation":"Palladini G, Barassi A, Klersy C, Pacciolla R, Milani P, Sarais G, Perlini S, Albertini R, Russo P, Foli A, Bragotti LZ, Obici L, Moratti R, Melzi d'Eril GV, Merlini G. The combination of high-sensitivity cardiac troponin T (hs-cTnT) at presentation and changes in N-terminal natriuretic peptide type B (NT-proBNP) after chemotherapy best predicts survival in AL amyloidosis. Blood. 2010 Nov 4;116(18):3426-30. doi: 10.1182/blood-2010-05-286567. Epub 2010 Jul 19."
              },{
                "ReferencePMID":"12719281",
                "ReferenceType":"background",
                "ReferenceCitation":"Palladini G, Campana C, Klersy C, Balduini A, Vadacca G, Perfetti V, Perlini S, Obici L, Ascari E, d'Eril GM, Moratti R, Merlini G. Serum N-terminal pro-brain natriuretic peptide is a sensitive marker of myocardial dysfunction in AL amyloidosis. Circulation. 2003 May 20;107(19):2440-5. Epub 2003 Apr 28."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Related Info",
                "SeeAlsoLinkURL":"http://www.amiloidosi.it/"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000000638",
                "InterventionMeshTerm":"Amiodarone"
              },{
                "InterventionMeshId":"D000004232",
                "InterventionMeshTerm":"Diuretics"
              },{
                "InterventionMeshId":"D000000889",
                "InterventionMeshTerm":"Anti-Arrhythmia Agents"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000045283",
                "InterventionAncestorTerm":"Natriuretic Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000014665",
                "InterventionAncestorTerm":"Vasodilator Agents"
              },{
                "InterventionAncestorId":"D000026902",
                "InterventionAncestorTerm":"Potassium Channel Blockers"
              },{
                "InterventionAncestorId":"D000049990",
                "InterventionAncestorTerm":"Membrane Transport Modulators"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000026941",
                "InterventionAncestorTerm":"Sodium Channel Blockers"
              },{
                "InterventionAncestorId":"D000065609",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP1A2 Inhibitors"
              },{
                "InterventionAncestorId":"D000065607",
                "InterventionAncestorTerm":"Cytochrome P-450 Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000065688",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP2C9 Inhibitors"
              },{
                "InterventionAncestorId":"D000065690",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP2D6 Inhibitors"
              },{
                "InterventionAncestorId":"D000065692",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP3A Inhibitors"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M5994",
                "InterventionBrowseLeafName":"Diuretics",
                "InterventionBrowseLeafAsFound":"Diuretic",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2557",
                "InterventionBrowseLeafName":"Amiodarone",
                "InterventionBrowseLeafAsFound":"Amiodarone",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2794",
                "InterventionBrowseLeafName":"Anti-Arrhythmia Agents",
                "InterventionBrowseLeafAsFound":"Antiarrhythmic drug",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M15995",
                "InterventionBrowseLeafName":"Vasodilator Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M21755",
                "InterventionBrowseLeafName":"Potassium Channel Blockers",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M28612",
                "InterventionBrowseLeafName":"Diuretics, Potassium Sparing",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M21761",
                "InterventionBrowseLeafName":"Sodium Channel Blockers",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M29124",
                "InterventionBrowseLeafName":"Cytochrome P-450 Enzyme Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M29151",
                "InterventionBrowseLeafName":"Cytochrome P-450 CYP3A Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"AnArAg",
                "InterventionBrowseBranchName":"Anti-Arrhythmia Agents"
              },{
                "InterventionBrowseBranchAbbrev":"ChanBlk",
                "InterventionBrowseBranchName":"Channel Blockers"
              },{
                "InterventionBrowseBranchAbbrev":"VaDiAg",
                "InterventionBrowseBranchName":"Vasodilator Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000075363",
                "ConditionMeshTerm":"Immunoglobulin Light-chain Amyloidosis"
              },{
                "ConditionMeshId":"D000000686",
                "ConditionMeshTerm":"Amyloidosis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000057165",
                "ConditionAncestorTerm":"Proteostasis Deficiencies"
              },{
                "ConditionAncestorId":"D000008659",
                "ConditionAncestorTerm":"Metabolic Diseases"
              },{
                "ConditionAncestorId":"D000054219",
                "ConditionAncestorTerm":"Neoplasms, Plasma Cell"
              },{
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000008232",
                "ConditionAncestorTerm":"Lymphoproliferative Disorders"
              },{
                "ConditionAncestorId":"D000007160",
                "ConditionAncestorTerm":"Immunoproliferative Disorders"
              },{
                "ConditionAncestorId":"D000007154",
                "ConditionAncestorTerm":"Immune System Diseases"
              },{
                "ConditionAncestorId":"D000010265",
                "ConditionAncestorTerm":"Paraproteinemias"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M1483",
                "ConditionBrowseLeafName":"Immunoglobulin Light-chain Amyloidosis",
                "ConditionBrowseLeafAsFound":"AL Amyloidosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M2602",
                "ConditionBrowseLeafName":"Amyloidosis",
                "ConditionBrowseLeafAsFound":"Amyloidosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M26175",
                "ConditionBrowseLeafName":"Neoplasms, Plasma Cell",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9808",
                "ConditionBrowseLeafName":"Lymphoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8789",
                "ConditionBrowseLeafName":"Immunoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11761",
                "ConditionBrowseLeafName":"Paraproteinemias",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T254",
                "ConditionBrowseLeafName":"AL Amyloidosis",
                "ConditionBrowseLeafAsFound":"AL Amyloidosis",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC15",
                "ConditionBrowseBranchName":"Blood and Lymph Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}