Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-01 @ 1:37 AM
Study NCT ID:
NCT00881933
Status:
UNKNOWN
Last Update Posted:
2012-03-26
First Post:
2009-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Fludarabine + Cyclophosphamide + TBI Conditioning Regimen for Double Units Cord Blood Transplantation(CBT)in Severe Aplastic Anemia(SAA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000741', 'term': 'Anemia, Aplastic'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014916', 'term': 'Whole-Body Irradiation'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2009-04-14', 'studyFirstSubmitQcDate': '2009-04-14', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the engraftment potential of fludarabine, busulfan plus thymoglobulin conditioning regimen for cord blood transplantation (CBT) in severe aplastic anemia.', 'timeFrame': 'From Oct 2008. to Sep 2011'}], 'secondaryOutcomes': [{'measure': 'To evaluate the incidence and severity of toxicity and treatment related mortality', 'timeFrame': 'From Oct 2008. to Sep 2011'}, {'measure': 'To evaluate overall and event free survival rate', 'timeFrame': 'From Oct 2008. to Sep 2011'}, {'measure': 'To evaluate acute and chronic GVHD', 'timeFrame': 'From Oct 2008. to Sep 2011'}, {'measure': 'To evaluate immunologic recovery after CBT', 'timeFrame': 'From Oct 2008. to Sep 2011'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fludarabine, Cyclophosphamide, TBI, severe aplastic anemia,', 'cord blood transplantation, pediatric'], 'conditions': ['Aplastic Anemia']}, 'descriptionModule': {'briefSummary': 'Severe aplastic anemia is a fatal disease and patients without HLA matched siblings need alternative treatment option. Cord blood transplantation (CBT) has become an alternative treatment means in various diseases, but it has not been proved to be good for severe aplastic anemia. Double units CBT is proposed to have better engraftment potential and and we reported successful double units UCBT after engraftment failure with single unit with promising result. To increase the engraftment potential, fludarabine, cyclophosphamide plus TBI conditioning regimen for double units cord blood transplantation was proposed for the patient with severe aplastic anemia without HLA-matched donor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria and either marrow criterion.\n* Peripheral blood\n\n * Neutrophils \\< 0.5 x 109/l\n * Platelets \\< 20 x 109/l\n * Corrected reticulocytes \\< 1%\n* Bone marrow\n\n * Severe hypocellularity (\\< 25%)\n * Moderate hypocellularity (25-30%) with hematopoietic cells representing \\< 30% of residual cells\n* No prior hematopoietic stem cell transplantation.\n* Age: no limits.\n* Performance status: ECOG 0-2.\n* Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.\n\n * Heart: a shortening fraction \\> 30%, ejection fraction \\> 45%.\n * Liver: total bilirubin \\< 2 × upper limit of normal; ALT \\< 3 × upper limit of normal.\n * Kidney: creatinine \\<2 × normal or a creatinine clearance (GFR) \\> 60 ml/min/1.73m2.\n* Patients must lack any active viral infections or active fungal infection.\n* No appropriate donor\n* Appropriate cord blood is available: matched at least in 4/6 of A, B, DR loci.\n* Patients (or one of parents if patients age \\< 19) should sign informed consent.\n\nExclusion Criteria:\n\n* Pregnant or nursing women.\n* Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.\n* Psychiatric disorder that would preclude compliance.\n* Congenital aplastic anemia including Fanconi anemia.'}, 'identificationModule': {'nctId': 'NCT00881933', 'briefTitle': 'Study of Fludarabine + Cyclophosphamide + TBI Conditioning Regimen for Double Units Cord Blood Transplantation(CBT)in Severe Aplastic Anemia(SAA)', 'organization': {'class': 'NETWORK', 'fullName': 'The Korean Society of Pediatric Hematology Oncology'}, 'officialTitle': 'Phase I/II Study of Fludarabine, Cyclophosphamide Plus TBI Conditioning Regimen for Double Units Cord Blood Transplantation in Severe Aplastic Anemia', 'orgStudyIdInfo': {'id': 'KSPHO-SCT0804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fludarabine', 'interventionNames': ['Other: Cyclophosphosphamide, TBI']}], 'interventions': [{'name': 'Cyclophosphosphamide, TBI', 'type': 'OTHER', 'description': 'fludarabine (30 mg/m2 once daily i.v. on days -7, -6, -5, -4, -3, \\& -2) (if body weight \\< 10 kg or if age \\< 1 year: 1.33 mg/kg) cyclophosphamide (60 mg/kg once daily i.v. on days -9, \\& -8) total body irradiation (3G on days -1)', 'armGroupLabels': ['Fludarabine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyo Seop Ahn, M.D, Ph.D', 'role': 'CONTACT', 'email': 'hsahn@snu.ac.kr', 'phone': '82 2 2072 3625'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyoung Jin Kang, M.D, Ph.D', 'role': 'CONTACT', 'email': 'kanghj@snu.ac.kr', 'phone': '82 2 2072 3304'}, {'name': 'Ji Won Lee, M.D', 'role': 'CONTACT', 'email': 'agnesjw@hanmail.net', 'phone': '82 2 2072 0177'}], 'overallOfficials': [{'name': 'Hyo Seop Ahn, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Korean Society of Pediatric Hematology Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Korean Society of Pediatric Hematology Oncology', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'The Korean Society of Hematology', 'oldOrganization': 'The Korean Society of Pediatric Hematology Oncology'}}}}