Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-01-01 @ 12:31 AM
Study NCT ID:
NCT01274195
Status:
UNKNOWN
Last Update Posted:
2013-11-19
First Post:
2011-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002066', 'term': 'Busulfan'}], 'ancestors': [{'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-17', 'studyFirstSubmitDate': '2011-01-10', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate 1-year event free survival after hematopoietic stem cell transplantation.', 'timeFrame': 'For 4 days used Buslufan through pharmacokinetic study in hematopoietic stem cell transplantation', 'description': 'To evaluate 1-year event free survival after hematopoietic stem cell transplantation.'}], 'secondaryOutcomes': [{'measure': 'To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate.', 'timeFrame': '1, 3, 6 and 12 months after transplantation', 'description': 'To evaluate engraftment rate, toxicities associated with hematopoietic stem cell transplantation, acute and chronic GVHD, treatment related mortality and relapse rate.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hematopoietic stem cell transplantation'], 'conditions': ['Hematopoietic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'In this study we plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.', 'detailedDescription': 'Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who are diagnosed as AML.\n2. Patients who need hematopoietic stem cell transplantation with busulfan based conditioning regimen.\n3. Age: up to 21 years\n4. Performance status: ECOG 0-2.\n5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction \\> 30% and ejection fraction \\> 45%. 2. Liver: total bilirubin \\< 2 × upper limit of normal; ALT \\< 3 × upper limit of normal. 3. Kidney: creatinine \\<2 × normal or a creatinine clearance (GFR) \\> 60 ml/min/1.73m2.\n6. Patients must lack any active viral infections or active fungal infection.\n7. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.\n8. Patients (or one of parents if patients age \\< 20) should sign informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or nursing women.\n2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.\n3. Psychiatric disorder that would preclude compliance.'}, 'identificationModule': {'nctId': 'NCT01274195', 'briefTitle': 'Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Hematopoietic Stem Cell Transplantation With Targeted Busulfan and Fludarabine in Pediatric AML', 'orgStudyIdInfo': {'id': 'SNUCH-SCT -1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Busulfan', 'interventionNames': ['Drug: Busulfan']}], 'interventions': [{'name': 'Busulfan', 'type': 'DRUG', 'description': 'First dose: busulfan (120 mg/m2 ivs once daily) (if age\\<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study', 'armGroupLabels': ['Busulfan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Daehangno, Jongno-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyoung Jin Kang, MD, PhD', 'role': 'CONTACT', 'email': 'kanghj@snu.ac.kr', 'phone': '82 2 2072 0177'}, {'name': 'Ji Won Lee, MD', 'role': 'CONTACT', 'email': 'agnesjw@hanmail.net', 'phone': '82 2 2072 0177'}, {'name': 'Hyo Seop Ahn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyoung Jin Kang, MD, PhD', 'role': 'CONTACT', 'email': 'kanghj@snu.ac.kr', 'phone': '82 2 2072 0177'}, {'name': 'Ji Won Lee, MD', 'role': 'CONTACT', 'email': 'agnesjw@hanmail.net', 'phone': '82 2 2072 0177'}], 'overallOfficials': [{'name': 'Hyoung Jin Kang, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}}}}