Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-06 @ 11:08 AM
Study NCT ID:
NCT04937634
Status:
UNKNOWN
Last Update Posted:
2023-02-06
First Post:
2021-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}], 'ancestors': [{'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2021-03-28', 'studyFirstSubmitQcDate': '2021-06-23', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Melphalan concentration', 'timeFrame': 'pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI', 'description': 'Analysis: Maximum Concentration observed (Cmax)'}, {'measure': 'Melphalan concentration', 'timeFrame': 'pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI', 'description': 'Analysis: Time of Maximum concentration observed (Tmax)'}, {'measure': 'Melphalan concentration', 'timeFrame': 'pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI', 'description': 'Analysis: Area Under the Curve'}, {'measure': 'Melphalan concentration', 'timeFrame': 'pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI', 'description': 'Analysis: Half lite (T1/2)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient who will receive a conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation (HSCT).\n* Age is below 19 at the time of diagnosis of a disease which is HSCT indication\n* Written Study Informed consent and/or assent from the patient, parent, or guardian\n\nExclusion Criteria:\n\n* Female patients who are pregnant or breast feeding\n* Study treatment would deteriorate patient's disease.\n* The patient may have problems with study participation due to a psychotic disorder.\n* Any condition that would, in the Investigator's judgement, interfere with participation in the study"}, 'identificationModule': {'nctId': 'NCT04937634', 'briefTitle': 'Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'SNUCH-MIDD-Mel'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Melphalan', 'interventionNames': ['Drug: Melphalan']}], 'interventions': [{'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['Conditioning regimen including melphalan for hematopoietic stem cell transplantation'], 'description': 'The subject receives conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation. Dosage of melphalan is 50mg/m\\^2/day. Infuse Melphalan over 30 minutes.', 'armGroupLabels': ['Melphalan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyoung Jin Kang, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyoung Jin Kang, MD', 'role': 'CONTACT', 'email': 'kanghj@snu.ac.kr', 'phone': '+82-2-2072-3452'}], 'overallOfficials': [{'name': 'Hyoung Jin Kang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Food and Drug Safety Evaluation (Republic of Korea)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}