{
  "FullStudy":{
    "Rank":217804,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516619",
          "OrgStudyIdInfo":{
            "OrgStudyId":"ProRom"
          },
          "Organization":{
            "OrgFullName":"IRCCS San Raffaele",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Secondary Prophylaxis in Non-Hodgkin Lymphoma (NHL) and Chemotherapy-induced Thrombocytopenia",
          "OfficialTitle":"Pilot Phase II Trial on Safety and Activity of Secondary Prophylaxis With Romiplostim in Patients With Non-Hodgkin Lymphoma and Chemotherapy-induced Thrombocytopenia",
          "Acronym":"ProRom"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2014",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 8, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 24, 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"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Amgen",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a monocentric, prospective phase II trial addressing safety and capability to prevent grade-4 Chemotherapy-induced Thrombocytopenia (CIT) of romiplostim in patients with NHL.",
          "DetailedDescription":"High-dose chemotherapy followed by autologous stem cell transplant is considered standard of care for patients with relapsed and/or refractory aggressive lymphomas. High-dose chemotherapy, with or without ASCT, may also be used as upfront chemotherapy according to lymphoma histotype (e.g. primary central nervous system lymphomas, mantle cell lymphomas), advanced stage disease, extranodal involvement, and high IPI. Chemotherapy-induced myelosuppression results in various degrees of neutropenia, anemia, and thrombocytopenia and related complications can lead to hospitalization, impaired quality of life, death, and increased healthcare costs.\n\nWhile myeloid growth factors have reduced neutropenia and the incidence of neutropenic fever, and erythropoietic agents have reduced anemia and transfusions, chemotherapy-induced thrombocytopenia (CIT) still remains an unmet treatment need.\n\nThrombocytopenia is significantly associated with increased bleeding risk, platelet transfusions need, chemotherapy dose reductions and treatment delays, which usually compromise therapeutic efficacy. Platelet transfusions are also limited by cost, supply, and associated risks, such as transfusion reactions, transmission of infection, alloimmunization and platelet refractoriness. Alternative strategies are evaluating pharmacologic options to stimulate platelet production and to overcome CIT.\n\nThe predominant reason for a low platelet count in cancer patients receiving chemotherapy is a deficiency in platelet production. Megakaryopoiesis, the process of development of mega-karyocytes and production of platelets, involves a highly complex cascade of events, from differentiation of immature progenitors to maturation of megakaryocytes and release of platelets into the bone marrow sinusoids. Cytokines present within specialized bone marrow niches contribute to survival, proliferation, and differentiation of megakaryocytes. In addition to TPO, an essential growth factor for platelet production, there are several other growth factors and cytokines, such as IL-1, IL-3, IL-6, IL-11, and SCF, that contribute towards megakaryopoiesis at different stages of development and maturation. In the last decade, a number of these cytokines have been evaluated for the prevention and treatment of thrombocytopenia. Unfortunately, none has yet provided a commercially available agent with a high therapeutic index.\n\nDespite very promising thrombopoietic activity, the clinical development of first-generation recombinant TPOs was halted due to immunogenicity concerns. This led to the development of TPO agonists with no homology to TPO that can bind the TPO receptors and activate signal-ling, leading to increase in platelet production."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Non-Hodgkin Lymphoma"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "NHL",
              "chemotherapy-induced grade-4 thrombocytopenia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"20",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"romiplostim",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Romiplostim"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Romiplostim",
                "InterventionDescription":"Romiplostim will be administered subcutaneously at a dose of 250 μg on the 1st, 3rd and 5th days after the last day of chemotherapy delivery and, then, every two days until the achievement of 75.000 plt/μL.\n\nIn the case of unsuccessful use of romiplostim after the second chemotherapy course, dose escalation to 500 μg/day, with the same above-mentioned schedule, will be indicated after the third course and for all the further courses, with a maximum of 8.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "romiplostim"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "chemotherapy-induced thrombocytopenia",
                    "Nplate"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"safety",
                "PrimaryOutcomeDescription":"evaluation of safety, defined by the incidence of grade >/= 4 adverse events (NCI CTCAE v. 4.02 Dec 2009)",
                "PrimaryOutcomeTimeFrame":"participants will be followed for the duration of experimental treatment, an expected average of 6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"activity",
                "SecondaryOutcomeDescription":"activity defined by the incidence of grade 4 CIT (</= 25 x 10E9/L) per chemotherapy course during experimental treatment",
                "SecondaryOutcomeTimeFrame":"From date of registration until the completion of chemotherapy treatment, an expected average of 6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatient with NHL of any histotype, both at diagnosis or at relapse, who experienced grade 4 CIT after the first course of chemotherapy containing high doses of methotrexate, cytarabine, cisplatin, cyclophosphamide and/or ifosfamide, and/or conventional doses of anthracyclines or purine analogs, with or without rituximab. The same type of chemotherapy where the grade 4 CIT occurred will be continued at the same planned doses for a maximum of 8 courses.\nECOG performance status score </= 3.\nAdequate bone marrow function (ANC >1.000; Hb >9,5 g/dL; PLT > 75.000).\n\nExclusion Criteria:\n\nPatients eligible for high-dose chemotherapy, where stem cell support is planned.\nThrombotic events in the previous 5 years before enrolment.\nOther malignancies diagnosed in the previous 5 years before enrolment.\nSevere concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus).\nActive infectious disease.\nImpaired liver function (bilirubin >2 x upper normal limit; ALT/AST/GGT > 3 x upper normal limit) at one month from salvage chemotherapy conclusion.\nImpaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion.\nNon-cooperative behavior or non-compliance.\nPsychiatric diseases or conditions that might impair the ability to give informed consent.\nPregnant or lactating females.\nPrevious therapy with any TPO-mimetic or similar substances.\nPrevious therapy supported by transplant of autologous or allogeneic stem cells",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Andrés JM Ferreri, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+39022643",
                "CentralContactPhoneExt":"7649",
                "CentralContactEMail":"ferreri.andres@hsr.it"
              },{
                "CentralContactName":"Silvia Govi, MD",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+39022643",
                "CentralContactPhoneExt":"7612",
                "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":"Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor",
                "LocationStatus":"Recruiting",
                "LocationCity":"Milano",
                "LocationCountry":"Italy",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Andrés JM Ferreri, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"+39022643",
                      "LocationContactPhoneExt":"7649",
                      "LocationContactEMail":"ferreri.andres@hsr.it"
                    },{
                      "LocationContactName":"Silvia Govi, MD",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"+39022643",
                      "LocationContactPhoneExt":"7612",
                      "LocationContactEMail":"govi.silvia@hsr.it"
                    },{
                      "LocationContactName":"Andrés JM Ferreri, MD",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008223",
                "ConditionMeshTerm":"Lymphoma"
              },{
                "ConditionMeshId":"D000008228",
                "ConditionMeshTerm":"Lymphoma, Non-Hodgkin"
              },{
                "ConditionMeshId":"D000013921",
                "ConditionMeshTerm":"Thrombocytopenia"
              }
            ]
          },
          "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":"D000001791",
                "ConditionAncestorTerm":"Blood Platelet Disorders"
              },{
                "ConditionAncestorId":"D000006402",
                "ConditionAncestorTerm":"Hematologic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9803",
                "ConditionBrowseLeafName":"Lymphoma",
                "ConditionBrowseLeafAsFound":"Lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10890",
                "ConditionBrowseLeafName":"Neoplasm Metastasis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15263",
                "ConditionBrowseLeafName":"Thrombocytopenia",
                "ConditionBrowseLeafAsFound":"Thrombocytopenia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9805",
                "ConditionBrowseLeafName":"Lymphoma, Non-Hodgkin",
                "ConditionBrowseLeafAsFound":"Non-Hodgkin's Lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10898",
                "ConditionBrowseLeafName":"Neoplasms by Histologic Type",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9808",
                "ConditionBrowseLeafName":"Lymphoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9786",
                "ConditionBrowseLeafName":"Lymphatic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8789",
                "ConditionBrowseLeafName":"Immunoproliferative Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8783",
                "ConditionBrowseLeafName":"Immune System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3654",
                "ConditionBrowseLeafName":"Blood Platelet Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8073",
                "ConditionBrowseLeafName":"Hematologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T3556",
                "ConditionBrowseLeafName":"Lymphosarcoma",
                "ConditionBrowseLeafAsFound":"Lymphoma",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC15",
                "ConditionBrowseBranchName":"Blood and Lymph Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}