Nctid:
NCT06617286
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008223", "term"=>"Lymphoma"}, {"id"=>"D000006689", "term"=>"Hodgkin Disease"}], "ancestors"=>[{"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000008232", "term"=>"Lymphoproliferative Disorders"}, {"id"=>"D000008206", "term"=>"Lymphatic Diseases"}, {"id"=>"D000007160", "term"=>"Immunoproliferative Disorders"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M11220", "name"=>"Lymphoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M9751", "name"=>"Hodgkin Disease", "asFound"=>"Hodgkin Lymphoma", "relevance"=>"HIGH"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11225", "name"=>"Lymphoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M11203", "name"=>"Lymphatic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"T3543", "name"=>"Lymphosarcoma", "asFound"=>"Lymphoma", "relevance"=>"HIGH"}, {"id"=>"T2817", "name"=>"Hodgkin Lymphoma", "asFound"=>"Hodgkin Lymphoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1", "PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>27}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-06-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2041-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-09", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2040-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Safety of administering CAR T-cells", "timeFrame"=>"2 years", "description"=>"To evaluate the incidence of adverse events related to autologous CD30+ CAR T-cell infusions including infusions related reactions (IRR), cytokine release syndrome (CRS), and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) in children, adolescent, and young adult patients with poor-risk CD30+ cHL following MAC ASCT."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["classical Hodgkin lymphoma", "CAR T-cells"], "conditions"=>["Classical Hodgkin Lymphoma"]}, "descriptionModule"=>{"briefSummary"=>"Patients with poor risk classical Hodgkin Lymphoma will undergo myeloablative chemotherapy with autologous stem cell transplantation followed by autologous CD30 CAR T-cells.", "detailedDescription"=>"Eligible patients will be screened for study entry and proceed to cell procurement with collection of peripheral blood for CD30 CAR T-cell manufacturing at UNC. Patients will then have autologous stem cells collected and stored.\n\nAfter another screening for myeloablative chemotherapy and autologous stem cell transplantation, patients who meeting criteria will receive BEAM high dose conditioning chemotherapy following by autologous stem cell transplantation. About 21-42 day after the autologous stem cell infusion, patients will receive their autologous CD30 CAR T-cell infusion."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"29 years", "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age between ≥ 6 and ≤ 29.99 years at the time of consent.\n* Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)\n* Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo ASCT. Must meet one of the following:\n\nInduction failure Progressive disease Disease relapse (1st, 2nd or 3rd)\n\n* CR2\n\n * Confirmatory re-biopsy of relapse/refractory/persistent CD30+ cHL prior to study entry.\n * Risk Factors: Patient must meet 2 or more of the established risk factors:\n\nPerformance score (Karnofsky/Lansky) \\<90% Time from diagnosis to first relapse of \\<1 year Extra nodal involvement at the time of relapse/progression High baseline metabolic tumor volume (MTV, \\>60mL) by 18F-fluorodeoxyglucose positron emission tomography (PET)/computed tomography (CT) Chemo resistant disease (Deauville 4-5) after the first re-induction\n\nExclusion Criteria:\n\n* not meeting the inclusion criteria"}, "identificationModule"=>{"nctId"=>"NCT06617286", "briefTitle"=>"CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma", "organization"=>{"class"=>"OTHER", "fullName"=>"New York Medical College"}, "officialTitle"=>"MAC-CAR: a Phase 1B/II Trial of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Autologous CD30+ CAR T Cells in Children, Adolescents and Young Adults with Poor-Risk Classical Hodgkin Lymphoma (cHL)", "orgStudyIdInfo"=>{"id"=>"NYMC 624"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"CD30 CAR T-cells", "description"=>"Patients will receive autologous CD30 CAR T-cells post autologous stem cell transplant between days 21-42.", "interventionNames"=>["Biological: CD30 CAR T-cell"]}], "interventions"=>[{"name"=>"CD30 CAR T-cell", "type"=>"BIOLOGICAL", "description"=>"Patients will have CD30 CAR T-cells manufactured and administered post autologous stem cell transplantation", "armGroupLabels"=>["CD30 CAR T-cells"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10595", "city"=>"Valhalla", "state"=>"New York", "country"=>"United States", "contacts"=>[{"name"=>"Mitchell S Cairo, MD", "role"=>"CONTACT", "email"=>"mitchell_cairo@nymc.edu", "phone"=>"914-594-2150"}], "facility"=>"New York Medical College", "geoPoint"=>{"lat"=>41.07482, "lon"=>-73.77513}}], "centralContacts"=>[{"name"=>"Mitchell S Cairo, MD", "role"=>"CONTACT", "email"=>"mitchell_cairo@nymc.edu", "phone"=>"914-594-2150"}, {"name"=>"Lauren Harrison, MSN", "role"=>"CONTACT", "email"=>"lauren_harrison@nymc.edu", "phone"=>"617-285-7844"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"New York Medical College", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"University of North Carolina", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
