Nctid:
NCT06228781
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009103", "term"=>"Multiple Sclerosis"}, {"id"=>"D000012598", "term"=>"Sclerosis"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000020278", "term"=>"Demyelinating Autoimmune Diseases, CNS"}, {"id"=>"D000020274", "term"=>"Autoimmune Diseases of the Nervous System"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000003711", "term"=>"Demyelinating Diseases"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M12060", "name"=>"Multiple Sclerosis", "asFound"=>"Multiple Sclerosis", "relevance"=>"HIGH"}, {"id"=>"M15415", "name"=>"Sclerosis", "asFound"=>"Sclerosis", "relevance"=>"HIGH"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M22098", "name"=>"Demyelinating Autoimmune Diseases, CNS", "relevance"=>"LOW"}, {"id"=>"M22094", "name"=>"Autoimmune Diseases of the Nervous System", "relevance"=>"LOW"}, {"id"=>"M6909", "name"=>"Demyelinating Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M6727", "name"=>"Cyclophosphamide", "relevance"=>"LOW"}, {"id"=>"M283230", "name"=>"Fludarabine", "relevance"=>"LOW"}, {"id"=>"M6766", "name"=>"Cytarabine", "relevance"=>"LOW"}, {"id"=>"M5336", "name"=>"Busulfan", "relevance"=>"LOW"}, {"id"=>"M225513", "name"=>"Fludarabine phosphate", "relevance"=>"LOW"}, {"id"=>"M17958", "name"=>"Idarubicin", "relevance"=>"LOW"}, {"id"=>"M19625", "name"=>"Cladribine", "relevance"=>"LOW"}, {"id"=>"M1945", "name"=>"Lenograstim", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-12-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2029-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-09", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-10", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2029-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"3 year MS activity free survival", "timeFrame"=>"3 year follow-up post transplant", "description"=>"The events for the primary outcome are: clinical relapse, appearance of a new or Gd-enhancing lesion on MRI, or sustained progression of EDSS score."}], "secondaryOutcomes"=>[{"measure"=>"Time to MS treatment failure", "timeFrame"=>"3 years", "description"=>"Disease activity and disability will be assessed with clinical relapse, appearance of a new or Gd-enhancing lesion on MRI, or sustained progression of EDSS score and quality of life."}, {"measure"=>"Transplant related morbidity", "timeFrame"=>"3 years", "description"=>"Rate of transplant related events."}, {"measure"=>"Transplant related mortality", "timeFrame"=>"3 years", "description"=>"Rate of transplant related death."}, {"measure"=>"Immune reconstitution following transplant", "timeFrame"=>"3 years", "description"=>"Rate of immune reconstitution following transplant."}, {"measure"=>"Hematopoietic reconstitution following transplant", "timeFrame"=>"3 years", "description"=>"Rate of hematopoietic reconstitution following transplant."}, {"measure"=>"Imaging changes associated with the disease activity", "timeFrame"=>"3 years", "description"=>"Imaging changes include:\n\nnew or enlarging T2-weighted lesion count and new T1-weighted lesion count at all scans after baseline; T2-weighted lesion volume; Gd-enhanced lesion count and volume; and total volume of non-enhancing T1-weighted lesions on all MRI scans."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Multiple Sclerosis"]}, "descriptionModule"=>{"briefSummary"=>"Autologous hematopoietic stem cell transplantation (aHSCT) is the only treatment for refractory autoimmune diseases capable of inducing long-term, drug-free and asymptomatic remission. Over the past two decades, aHSCT has been used to treat inflammatory autoimmune disease of the CNS. Patients with relapsing-remitting multiple sclerosis benefit from aHSCT treatment. However, a certain percentage of patients still experience recurrence 3 or 5 years after transplantation. Therefore, exploration of conditioning regimens will drive therapeutic advances in aHSCT in autoimmune diseases of the CNS."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age 18-60 years;\n2. Diagnosed multiple sclerosis with relapses or progression and sustained accumulated impairment by a neurologist expert in the field;\n3. EDSS score of 3-6 (including 3 and 6);\n4. EDSS cerebellar functional score ≥ 3 or EDSS pyramidal functional score ≥3；\n5. Evidence of current disease activity;\n6. If a patient has previously received a cytotoxic agent (mitoxantrone, cyclophosphamide etc.) they must have normal bone marrow morphology and cytogenetics before being considered eligible for this study ;\n7. No evidence of hepatic inflammation or fibrosis;\n\nExclusion Criteria:\n\n1. Patients with evidence of myelodysplasia or other non-autoimmune cytopenia;\n2. Patients having received a cytotoxic agent within one month of enrolling in this study;\n3. Patient with any active or chronic infection (herpes simplex virus, varicella-zoster virus, cytomegalovirus, EB virus, human immunodeficiency virus, hepatitis virus, syphilis, etc.);\n4. Patients having received a cytotoxic agent within one month of enrolling in this study;\n5. Patients with a malignant tumor currently or within the last 5 years;\n6. Patients with cardiac, renal, pulmonary, hepatic or other organ impairment;\n7. Patients whose life expectancy is severely limited by another conditions;\n8. Pregnancy or risk of pregnancy;\n9. Patients unable to give written informed consent in accordance with research ethics board guidelines."}, "identificationModule"=>{"nctId"=>"NCT06228781", "briefTitle"=>"Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis", "organization"=>{"class"=>"OTHER", "fullName"=>"Tianjin Medical University General Hospital"}, "officialTitle"=>"Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis", "orgStudyIdInfo"=>{"id"=>"IRB2023-YX-233-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Hematopoietic Stem Cell Transplantation", "description"=>"Patients will undergo stem cell transplantation for the treatment of refractory MS", "interventionNames"=>["Procedure: Autologous haemopoietic stem cell transplantation"]}], "interventions"=>[{"name"=>"Autologous haemopoietic stem cell transplantation", "type"=>"PROCEDURE", "description"=>"Immuno-ablation and autologous CD34 selected hematopoietic stem cell transplantation (HSCT).\n\nStem cell mobilization with cyclophosphamide 2g/m2 and filgrastim 10 ug/kg/d x 5 day.\n\nStem cell collection with cobe cpectra stem cell purification with Miltenyi CliniMACS Stem cell transplant conditioning with busulphan 3.2 mg/kg ; fludarabine 30mg/m2 or cladribine 10mg ；cytarabine 1-2g/m2 or idarubicin 8mg/m2；cyclophosphamide 40mg/kg followed by CD34 selected autologous hematopoietic stem cell transplant.", "armGroupLabels"=>["Hematopoietic Stem Cell Transplantation"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Qiang Liu, M.D.,Ph.D", "role"=>"CONTACT", "email"=>"qliu@tmu.edu.cn", "phone"=>"+86 15022439149"}], "overallOfficials"=>[{"name"=>"Qiang Liu, M.D.,Ph.D", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Tianjin Medical University General Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tianjin Medical University General Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor of Department of Neurology", "investigatorFullName"=>"Qiang Liu", "investigatorAffiliation"=>"Tianjin Medical University General Hospital"}}}}
