{
  "FullStudy":{
    "Rank":217805,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516606",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HD-K"
          },
          "Organization":{
            "OrgFullName":"IRCCS San Raffaele",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma",
          "OfficialTitle":"Phase II Clinical Trial on the Activity of Salvage Therapy With High Dose Oral Clarithromycin in Patients With Relapsed or Refractory Extranodal Marginal Zone Lymphoma",
          "Acronym":"HD-K"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2014",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 6, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 19, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 25, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Andres J. M. Ferreri",
            "ResponsiblePartyInvestigatorTitle":"MD",
            "ResponsiblePartyInvestigatorAffiliation":"IRCCS San Raffaele"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Andres J. M. Ferreri",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a prospective, phase II study on the activity and tolerability of high dose (2 g/day) oral clarithromycin for the treatment of relapsed or refractory extranodal marginal zone lymphoma.",
          "DetailedDescription":"A 6-month regimen of oral clarithromycin has been associated with a 35% ORR in patients with relapsed/refractory marginal zone B-cell lymphoma. Responses were more common among patients with conjunctival lymphoma. This could be explained at least in part by the elimination of clarithromycin by tears, suggesting that a higher tumor bioavailability of this antibiotic could result in a higher activity. Thus, a higher dose of clarithromycin could be associated with a higher tumor bioavailability in tissues other than the conjunctiva."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Lymphoma"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "MALT",
              "refractory",
              "relapsed",
              "extranodal",
              "relapsed or refractory extranodal marginal zone lymphoma"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"19",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"clarithromycin, oral, high dose",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: clarithromycin, oral, high dose"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"clarithromycin, oral, high dose",
                "InterventionDescription":"2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "clarithromycin, oral, high dose"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "klacid"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"assessment of responses",
                "PrimaryOutcomeDescription":"evaluation of activity in terms of global responses, complete responses and duration of responses",
                "PrimaryOutcomeTimeFrame":"The best clinical response at 6 months from trial registration"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nhistologically confirmed diagnosis of extranodal extra-gastric marginal zone cell B lymphoma or gastric Helicobacter pylori positive lymphoma refractory to conventional antibiotic therapy, or H. pylori negative\nat least one measurable lesion\nrelapsed or refractory lymphoma after systemic (chemotherapy, immunotherapy, antibiotic) or local (surgery or radiation) therapy\nECOG PS </= 3\nno prior antibiotic therapy within 3 months before enrollment\n\nExclusion Criteria:\n\nHIV 1-2 infection\nconcomitant conventional or experimental antitumor therapy (chemotherapy, radiotherapy, immunotherapy, corticosteroids)\nsevere inadequate liver (AST </=3 ULN, ALT </= 3 ULN, bilirubin </=3 ULN) or renal (creatinine </= 1.5 ULN) function\nallergy to macrolides\nconcomitant malignant neoplasms within prior 5 years (with the exclusion of basal cell carcinoma, in situ spinocellular carcinoma of skin and cervix)",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Andrés JM Ferreri, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+30022643",
                "CentralContactPhoneExt":"7649",
                "CentralContactEMail":"ferreri.andres@hsr.it"
              },{
                "CentralContactName":"Silvia Govi, MD",
                "CentralContactRole":"Contact",
                "CentralContactEMail":"govi.silvia@hsr.it"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Andrés JM Ferreri, MD",
                "OverallOfficialAffiliation":"San Raffaele Scientific Institute, Milano, Italy",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Dpt of OncoHematology - Fondazione Centro San Raffaele del Monte Tabor",
                "LocationStatus":"Recruiting",
                "LocationCity":"Milan",
                "LocationCountry":"Italy",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Andrés JM Ferreri, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"+39022643",
                      "LocationContactPhoneExt":"7649",
                      "LocationContactEMail":"ferreri.andres@hsr.it"
                    },{
                      "LocationContactName":"Andrés JM Ferreri, MD",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25935794",
                "ReferenceType":"derived",
                "ReferenceCitation":"Ferreri AJ, Sassone M, Kiesewetter B, Govi S, Scarfò L, Donadoni G, Raderer M. High-dose clarithromycin is an active monotherapy for patients with relapsed/refractory extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT): the HD-K phase II trial. Ann Oncol. 2015 Aug;26(8):1760-5. doi: 10.1093/annonc/mdv214. Epub 2015 May 1."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000017291",
                "InterventionMeshTerm":"Clarithromycin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000900",
                "InterventionAncestorTerm":"Anti-Bacterial Agents"
              },{
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000011500",
                "InterventionAncestorTerm":"Protein Synthesis Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000065692",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP3A Inhibitors"
              },{
                "InterventionAncestorId":"D000065607",
                "InterventionAncestorTerm":"Cytochrome P-450 Enzyme Inhibitors"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M18168",
                "InterventionBrowseLeafName":"Clarithromycin",
                "InterventionBrowseLeafAsFound":"Clarithromycin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2803",
                "InterventionBrowseLeafName":"Anti-Bacterial Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M29151",
                "InterventionBrowseLeafName":"Cytochrome P-450 CYP3A Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M29124",
                "InterventionBrowseLeafName":"Cytochrome P-450 Enzyme Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008223",
                "ConditionMeshTerm":"Lymphoma"
              },{
                "ConditionMeshId":"D000018442",
                "ConditionMeshTerm":"Lymphoma, B-Cell, Marginal Zone"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009370",
                "ConditionAncestorTerm":"Neoplasms by Histologic Type"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000008232",
                "ConditionAncestorTerm":"Lymphoproliferative Disorders"
              },{
                "ConditionAncestorId":"D000008206",
                "ConditionAncestorTerm":"Lymphatic Diseases"
              },{
                "ConditionAncestorId":"D000007160",
                "ConditionAncestorTerm":"Immunoproliferative Disorders"
              },{
                "ConditionAncestorId":"D000007154",
                "ConditionAncestorTerm":"Immune System Diseases"
              },{
                "ConditionAncestorId":"D000016393",
                "ConditionAncestorTerm":"Lymphoma, B-Cell"
              },{
                "ConditionAncestorId":"D000008228",
                "ConditionAncestorTerm":"Lymphoma, Non-Hodgkin"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9803",
                "ConditionBrowseLeafName":"Lymphoma",
                "ConditionBrowseLeafAsFound":"Lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M19138",
                "ConditionBrowseLeafName":"Lymphoma, B-Cell, Marginal Zone",
                "ConditionBrowseLeafAsFound":"Marginal zone lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M17411",
                "ConditionBrowseLeafName":"Lymphoma, B-Cell",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9808",
                "ConditionBrowseLeafName":"Lymphoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9786",
                "ConditionBrowseLeafName":"Lymphatic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8789",
                "ConditionBrowseLeafName":"Immunoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9805",
                "ConditionBrowseLeafName":"Lymphoma, Non-Hodgkin",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T3556",
                "ConditionBrowseLeafName":"Lymphosarcoma",
                "ConditionBrowseLeafAsFound":"Lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T3626",
                "ConditionBrowseLeafName":"Marginal Zone Lymphoma",
                "ConditionBrowseLeafAsFound":"Marginal zone lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T642",
                "ConditionBrowseLeafName":"B-cell Lymphoma",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "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"
              }
            ]
          }
        }
      }
    }
  }
}