Nctid:
NCT00001637
Payload:
{"FullStudy"=>{"Rank"=>474069, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007938", "ConditionMeshTerm"=>"Leukemia"}, {"ConditionMeshId"=>"D000011289", "ConditionMeshTerm"=>"Preleukemia"}, {"ConditionMeshId"=>"D000007945", "ConditionMeshTerm"=>"Leukemia, Lymphoid"}, {"ConditionMeshId"=>"D000015451", "ConditionMeshTerm"=>"Leukemia, Lymphocytic, Chronic, B-Cell"}, {"ConditionMeshId"=>"D000009190", "ConditionMeshTerm"=>"Myelodysplastic Syndromes"}, {"ConditionMeshId"=>"D000006086", "ConditionMeshTerm"=>"Graft vs Host Disease"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000001855", "ConditionAncestorTerm"=>"Bone Marrow Diseases"}, {"ConditionAncestorId"=>"D000006402", "ConditionAncestorTerm"=>"Hematologic Diseases"}, {"ConditionAncestorId"=>"D000011230", "ConditionAncestorTerm"=>"Precancerous Conditions"}, {"ConditionAncestorId"=>"D000008232", "ConditionAncestorTerm"=>"Lymphoproliferative Disorders"}, {"ConditionAncestorId"=>"D000008206", "ConditionAncestorTerm"=>"Lymphatic Diseases"}, {"ConditionAncestorId"=>"D000007160", "ConditionAncestorTerm"=>"Immunoproliferative Disorders"}, {"ConditionAncestorId"=>"D000007154", "ConditionAncestorTerm"=>"Immune System Diseases"}, {"ConditionAncestorId"=>"D000015448", "ConditionAncestorTerm"=>"Leukemia, B-Cell"}, {"ConditionAncestorId"=>"D000002908", "ConditionAncestorTerm"=>"Chronic Disease"}, {"ConditionAncestorId"=>"D000020969", "ConditionAncestorTerm"=>"Disease Attributes"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10635", "ConditionBrowseLeafName"=>"Leukemia", "ConditionBrowseLeafAsFound"=>"Leukemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10645", "ConditionBrowseLeafName"=>"Leukemia, Myeloid", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17813", "ConditionBrowseLeafName"=>"Leukemia, Myelogenous, Chronic, BCR-ABL Positive", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M16045", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17817", "ConditionBrowseLeafName"=>"Leukemia, Myeloid, Acute", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8879", "ConditionBrowseLeafName"=>"Graft vs Host Disease", "ConditionBrowseLeafAsFound"=>"Graft vs Host Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M27275", "ConditionBrowseLeafName"=>"Precursor Cell Lymphoblastic Leukemia-Lymphoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10641", "ConditionBrowseLeafName"=>"Leukemia, Lymphoid", "ConditionBrowseLeafAsFound"=>"Lymphocytic Leukemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21004", "ConditionBrowseLeafName"=>"Hematologic Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17806", "ConditionBrowseLeafName"=>"Leukemia, Lymphocytic, Chronic, B-Cell", "ConditionBrowseLeafAsFound"=>"Chronic Lymphocytic Leukemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M13854", "ConditionBrowseLeafName"=>"Preleukemia", "ConditionBrowseLeafAsFound"=>"Myelodysplastic Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M11835", "ConditionBrowseLeafName"=>"Myelodysplastic Syndromes", "ConditionBrowseLeafAsFound"=>"Myelodysplastic Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17812", "ConditionBrowseLeafName"=>"Leukemia, Prolymphocytic", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12005", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4824", "ConditionBrowseLeafName"=>"Bone Marrow Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9180", "ConditionBrowseLeafName"=>"Hematologic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13801", "ConditionBrowseLeafName"=>"Precancerous Conditions", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10915", "ConditionBrowseLeafName"=>"Lymphoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10893", "ConditionBrowseLeafName"=>"Lymphatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9896", "ConditionBrowseLeafName"=>"Immunoproliferative Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9890", "ConditionBrowseLeafName"=>"Immune System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17805", "ConditionBrowseLeafName"=>"Leukemia, B-Cell", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5837", "ConditionBrowseLeafName"=>"Chronic Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M22390", "ConditionBrowseLeafName"=>"Disease Attributes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1303", "ConditionBrowseLeafName"=>"Chronic Graft Versus Host Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3995", "ConditionBrowseLeafName"=>"Myeloid Leukemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1309", "ConditionBrowseLeafName"=>"Chronic Myeloid Leukemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T182", "ConditionBrowseLeafName"=>"Acute Myeloid Leukemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T188", "ConditionBrowseLeafName"=>"Acute Non Lymphoblastic Leukemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T2832", "ConditionBrowseLeafName"=>"Homologous Wasting Disease", "ConditionBrowseLeafAsFound"=>"Graft vs Host Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T175", "ConditionBrowseLeafName"=>"Acute Lymphoblastic Leukemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3533", "ConditionBrowseLeafName"=>"Lymphoblastic Lymphoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1308", "ConditionBrowseLeafName"=>"Chronic Lymphocytic Leukemia", "ConditionBrowseLeafAsFound"=>"Chronic Lymphocytic Leukemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T3993", "ConditionBrowseLeafName"=>"Myelodysplastic Syndromes", "ConditionBrowseLeafAsFound"=>"Myelodysplastic Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T170", "ConditionBrowseLeafName"=>"Acute Graft Versus Host Disease", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Blood and Lymph Conditions", "ConditionBrowseBranchAbbrev"=>"BC15"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Immune System Diseases", "ConditionBrowseBranchAbbrev"=>"BC20"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M6417", "InterventionBrowseLeafName"=>"Cyclophosphamide", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M283197", "InterventionBrowseLeafName"=>"Fludarabine", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9902", "InterventionBrowseLeafName"=>"Immunosuppressive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M225453", "InterventionBrowseLeafName"=>"Fludarabine phosphate", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Antirheumatic Agents", "InterventionBrowseBranchAbbrev"=>"ARhu"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Non-Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Single Group Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"28"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 29, 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 28, 2016", "CompletionDateStruct"=>{"CompletionDate"=>"December 28, 2016", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"December 14, 2019", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 17, 2019", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"July 28, 2008", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"The proportion of patients with clinically significant acute GHVD (Grade II or higher) following the T depleted PBPC transplant."}]}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Peripheral Blood Stem Cells", "Engraftment", "Fludarabine", "Nonmyeloablative", "Graft-Versus-Leukemia", "Graft vs. Host Disease", "Cyclophosphamide", "Donor Apheresis", "Nonmyeloablative Bone Marrow Transplantation", "Chronic Myelogenous Leukemia (CML)", "Acute Lymphoblastic Leukemia (ALL)", "Acute Myelogenous Leukemia (AML)", "Myelodysplastic Syndromes", "Chronic Lymphocytic Leukemia (CLL)", "Prolymphocytic Leukemia"]}, "ConditionList"=>{"Condition"=>["Chronic Lymphocytic Leukemia", "Graft vs Host Disease", "Leukemia", "Myelodysplastic Syndrome", "Myeloid Leukemia"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"7605984", "ReferenceType"=>"background", "ReferenceCitation"=>"Rowe JM, Andersen JW, Mazza JJ, Bennett JM, Paietta E, Hayes FA, Oette D, Cassileth PA, Stadtmauer EA, Wiernik PH. A randomized placebo-controlled phase III study of granulocyte-macrophage colony-stimulating factor in adult patients (> 55 to 70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490). Blood. 1995 Jul 15;86(2):457-62."}, {"ReferencePMID"=>"9192777", "ReferenceType"=>"background", "ReferenceCitation"=>"Giralt S, Estey E, Albitar M, van Besien K, Rondon G, Anderlini P, O'Brien S, Khouri I, Gajewski J, Mehra R, Claxton D, Andersson B, Beran M, Przepiorka D, Koller C, Kornblau S, Korbling M, Keating M, Kantarjian H, Champlin R. Engraftment of allogeneic hematopoietic progenitor cells with purine analog-containing chemotherapy: harnessing graft-versus-leukemia without myeloablative therapy. Blood. 1997 Jun 15;89(12):4531-6."}, {"ReferencePMID"=>"7534141", "ReferenceType"=>"background", "ReferenceCitation"=>"Schmitz N, Dreger P, Suttorp M, Rohwedder EB, Haferlach T, Loffler H, Hunter A, Russell NH. Primary transplantation of allogeneic peripheral blood progenitor cells mobilized by filgrastim (granulocyte colony-stimulating factor). Blood. 1995 Mar 15;85(6):1666-72."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Diseases such as leukemia, lymphoma, and multiple myeloma fall into the category of blood cancers. Some of these conditions can now be cured by bone marrow transplantation (BMT). The ability of BMT to cure these conditions has been credited to the use of high doses of chemotherapy, radiation therapy, and the antileukemia effect of the transplant.\n\nBecause the effectiveness of BMT relies on the use of high doses of chemotherapy and total body irradiation (TBI), it is a therapy associated with toxic side effects. These side effects are often deadly and have limited BMT for use in patients under the age of 55.\n\nIn this study researchers plan to treat older patients between the ages of 55 to 75 years with blood cell transplants taken from donors who are genetically matched relatives of the patient. In order to decrease the toxic side effects associated with the transplant, researchers will not use chemoradiotherapy. Instead they plan to use intensive immunosuppressive therapy and allow the transplanted cells to take effect.", "DetailedDescription"=>"Patients with adult leukemias, non-Hodgkin's lymphoma and multiple myeloma, can now be cured by allogeneic bone marrow transplantation (BMT). This curative effect has been ascribed to the use of high dose chemoradiotherapy and the antileukemia effect of the graft.\n\nThe assumption that BMT relies on the myeloablative effect of high dose chemotherapy and total body irradiation (TBI), has largely restricted allogeneic bone marrow transplantation in adults to those under the age of 55 years. Toxicity related mortality increases progressively with age and although some transplant centers carry out BMT in patients up to the age of 60 years, it is generally accepted that treatment related mortality prohibits the use of allogeneic bone marrow transplantation in patients beyond the age of 55 years.\n\nSeveral in vitro studies have demonstrated the existence of donor-derived CD4 and CD8 positive lymphocytes with specific reactivity for the patients leukemia and a potent graft versus leukemia (GVL) effect. This GVL effect is best seen in patients with relapse CML after bone marrow transplantation where a single infusion of donor lymphocytes can induce complete remission.\n\nIn this protocol, we treat older patients between the ages of 55 to 71 years with hematologic disorders with an allogeneic stem cell transplant from an HLA identical sibling, using intensive immunosuppressive regimen without myeloablation in attempts to decrease the transplant related toxicity while preserving the antileukemia effect of the graft. The low intensity nonmyeloablative conditioning regimen will provide adequate immunosuppression to allow stem cell and lymphocyte engraftment. T-cell replete, donor-derived, granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood stem cells (PBSC) will be used to establish hematopoietic and lymphoid immune reconstitution. We will add back lymphocytes in patients with less than 75% donor marrow chimerism as an attempt to prevent graft rejection.\n\nThe end points of this study are engraftment, degree of donor-host chimerism, incidence of acute and chronic GVHD, transplant related morbidity and mortality as well as survival."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"71 years", "MinimumAge"=>"55 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA - PATIENT:\n\nAges 55-71 years.\n\nChronic myelogenous leukemia (CML): chronic phase.\n\nAcute lymphoblastic leukemia (ALL), all patients in complete or partial remission.\n\nAcute myelogenous leukemia (AML): AML in first complete or partial remission. Exceptions: AML with good risk karyotypes: AML M3 t(5;17), AML M4Eo (inv. 16), AML t(8;21). All AML in second or subsequent complete remission.\n\nMyelodyplastic syndromes: refractory anemia with excess of blasts (less than 10%) or early transformation to acute leukemia or Chronic myelomonocytic leukemia.\n\nChronic lymphocytic leukemia (CLL) with bulky or progressive disease despite prior treatment with chemotherapy which includes purine analogs.\n\nMantle cell lymphoma.\n\nRelapsed or progressive non-Hodgkins lymphoma, failing standard treatment approaches and unsuitable for autologous stem cell transplantation.\n\nNo major organ dysfunction precluding transplantation.\n\nDLCO greater than or equal to 40% predicted.\n\nLeft ventricular ejection fraction: greater than 30% predicted.\n\nECOG performance status of 0-2.\n\nINCLUSION CRITERIA - DONOR:\n\nHLA identical family donor, up to 75 years old.\n\nFit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke, no history of severe heart disease).\n\nInformed consent given.\n\nEXCLUSION CRITERIA:\n\nPatient or donor pregnant or lactating.\n\nPatient age less than 55, greater than 71 years.\n\nECOG performance status of 3 or more. Psychiatric disorder or mental deficiency of the patient or the donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.\n\nMajor anticipated illness or organ failure incompatible with survival from BMT.\n\nDLCO less than 40% predicted.\n\nLeft ventricular ejection fraction less than 30% predicted.\n\nSerum creatinine greater than 2.5 mg/dl.\n\nSerum bilirubin greater than 4 mg/dl, transaminases greater than 5 times the upper limit of normal.\n\nHIV positive (donor or recipient). Donors who are positive for HBV, HCV, or HTLV will be used at the discretion of the investigator.\n\nOther malignant diseases liable to relapse or progress within 5 years.\n\nDonor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of heart failure or unstable angina, platelet count less than 90,000/cu mm)."}, "IdentificationModule"=>{"NCTId"=>"NCT00001637", "BriefTitle"=>"Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Low Intensity Preparative Regimen Followed by HLA-Matched, Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematologic Malignancies in Older Adults", "OrgStudyIdInfo"=>{"OrgStudyId"=>"970202"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-H-0202"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Blood cell transplantation", "InterventionType"=>"Procedure"}]}}, "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"=>"A. John Barrett, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Heart, Lung, and Blood Institute (NHLBI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}