Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT06041893
Status:
RECRUITING
Last Update Posted:
2024-12-03
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'To confirm the recovery of immune function, T (including Treg, Tmemory), B, and NK cell counts will be checked before hematopoietic stem cell transplantation and 1, 3, 6, and 12 months after transplantation.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immune reconstitution', 'timeFrame': 'From the date of transplantation until 365 days after transplantation', 'description': 'B cell, T cell (CD3+, CD4+, CD8+, Regulatory, Memory) NK cell count (of peripheral blood) at 1, 3, 6, 12 months post-transplantation'}], 'primaryOutcomes': [{'measure': 'Emgraftment Rate', 'timeFrame': 'From the date of transplantation until 28 days after transplantation', 'description': 'cumulative incidence of donor-dominant engraftment by day 28 (by case)'}, {'measure': 'Time to Engraftment', 'timeFrame': 'From the date of transplantation until first neutrophil count over 500/uL for 3 consecutive tays', 'description': 'median time to neutrophil engraftment'}, {'measure': 'Acute Graft-Versus-Host Disease', 'timeFrame': 'From the date of transplantation until 365 days after transplantation', 'description': 'Incidence of acute GVHD ≥ grade 2'}, {'measure': 'Chronic Graft-Versus-Host Disease', 'timeFrame': 'From the date of transplantation until the date of documentation of highest level of chronic GVHD, assessed up to 2 years after transplantation', 'description': 'Incidence of moderate to severe chronic GVHD'}], 'secondaryOutcomes': [{'measure': 'Rate of CMV infection', 'timeFrame': 'From the date of transplantation until 365 days after transplantation', 'description': 'Rate of CMV infection'}, {'measure': 'Rate of Hemorrhagic Cystitis', 'timeFrame': 'From the date of transplantation until 365 days after transplantation', 'description': 'Rate of Hemorrhagic Cystitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post transplant cyclophosphamide', 'antithymocyte globulin'], 'conditions': ['Haploidentical Hematopoietic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to investigate the effect of early administration of anti-thymocyte globulin and post-transplant low-dose cyclophosphamide in heploidentical hematopoietic stem cell transplantation.', 'detailedDescription': 'Hematopoietic stem cell transplantation from a haploidentical donor (haplo-HCT) are increasingly used in patients lacking a matched donor, but the optimal strategy needs to be defined. This study aims to investigate the outcome of haplo-HCT with early antithymocyte globulin and low dose posttransplant cyclophosphamide (ATG/LD-PTCy) in a single center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center.\n\nExclusion Criteria:\n\n* A clinical trial subject (legal representative, if applicable) who do not consent or is unable to give written consent.'}, 'identificationModule': {'nctId': 'NCT06041893', 'briefTitle': 'Haploidentical Hematopoietic Stem Cell Transplantation With Early ATG and Low Dose Post-transplant Cyclophosphamide', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Haploidentical Hematopoietic Stem Cell Transplantation With Early Antithymocyte Globulin and Low Dose Post-transplant Cyclophosphamide', 'orgStudyIdInfo': {'id': 'SMC 2023-03-094-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ATG/LD-PTCy group', 'description': 'Patients undergoing haploidentical hematopoietic stem cell transplantation with ATG and low-dose post-transplant cyclophosphamide conditioning at the department of pediatrics, Samsung Medical Center', 'interventionNames': ['Drug: ATG-LDPTCy']}], 'interventions': [{'name': 'ATG-LDPTCy', 'type': 'DRUG', 'description': 'antithymocyte globulin with low dose post-transplant cyclophosphamide', 'armGroupLabels': ['ATG/LD-PTCy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hee Young Ju', 'role': 'CONTACT', 'email': 'heeyoung.ju@samsung.com', 'phone': '82-10-3410-0865'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hee Young Ju', 'role': 'CONTACT', 'email': 'hyju320@gmail.com', 'phone': '82-02-3410-0865'}, {'name': 'Min Suk Rheu', 'role': 'CONTACT', 'email': 'minsuk.rheu@sbri.co.kr', 'phone': '82-02-3410-3607'}], 'overallOfficials': [{'name': 'Keon Hee Yoo, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'KeonHee Yoo', 'investigatorAffiliation': 'Samsung Medical Center'}}}}