Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 10:19 AM
Study NCT ID:
NCT04689750
Status:
RECRUITING
Last Update Posted:
2022-10-04
First Post:
2020-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Donor CHIP and Allogeneic HSCT Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood or bone marrow'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 850}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-03', 'studyFirstSubmitDate': '2020-12-24', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival (OS) of the recipient.', 'timeFrame': '5 years', 'description': 'This is defined as the time (in months) from the date of allo-HSCT to death from any cause (event), latest follow-up (censor) or study termination.'}, {'measure': 'Progression-free survival (PFS) of the recipient.', 'timeFrame': '5 years', 'description': 'This is defined as the time (in months) from the date of allo-HSCT to relapse/progression (event), death, latest follow-up or study termination.'}], 'secondaryOutcomes': [{'measure': 'Acute and chronic GVHD', 'timeFrame': '5 years', 'description': 'The occurrence of acute and/or chronic graft-versus-host disease'}, {'measure': 'Leukemia of donor origin', 'timeFrame': '5 years', 'description': 'The occurrence of donor cell derived MDS/AML in the recipient following allogeneic HSCT'}, {'measure': 'Cardiac complications', 'timeFrame': '5 years', 'description': 'The occurrence of arrthymias, pericardial disease, coronary artery disease, myocardial dysfunction, pulmonary hypertension'}, {'measure': 'Pulmonary complications', 'timeFrame': '5 years', 'description': 'The occurrence of bronchiolitis obliterans, bronchiolitis obliterans with organizing pneumonia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Donor clonal hematopoiesis', 'Allogeneic hematopoiectic stem cell transplantation', 'Outcome'], 'conditions': ['Clonal Hematopoiesis']}, 'referencesModule': {'references': [{'pmid': '25931582', 'type': 'BACKGROUND', 'citation': 'Steensma DP, Bejar R, Jaiswal S, Lindsley RC, Sekeres MA, Hasserjian RP, Ebert BL. Clonal hematopoiesis of indeterminate potential and its distinction from myelodysplastic syndromes. Blood. 2015 Jul 2;126(1):9-16. doi: 10.1182/blood-2015-03-631747. Epub 2015 Apr 30.'}, {'pmid': '31838005', 'type': 'BACKGROUND', 'citation': 'Steensma DP, Ebert BL. Clonal hematopoiesis as a model for premalignant changes during aging. Exp Hematol. 2020 Mar;83:48-56. doi: 10.1016/j.exphem.2019.12.001. Epub 2019 Dec 12.'}, {'pmid': '30078412', 'type': 'BACKGROUND', 'citation': 'Steensma DP. Clinical Implications of Clonal Hematopoiesis. Mayo Clin Proc. 2018 Aug;93(8):1122-1130. doi: 10.1016/j.mayocp.2018.04.002. Epub 2018 Jul 4.'}, {'pmid': '30482770', 'type': 'BACKGROUND', 'citation': 'Steensma DP. Clinical consequences of clonal hematopoiesis of indeterminate potential. Blood Adv. 2018 Nov 27;2(22):3404-3410. doi: 10.1182/bloodadvances.2018020222.'}, {'pmid': '24522528', 'type': 'BACKGROUND', 'citation': 'Shlush LI, Zandi S, Mitchell A, Chen WC, Brandwein JM, Gupta V, Kennedy JA, Schimmer AD, Schuh AC, Yee KW, McLeod JL, Doedens M, Medeiros JJ, Marke R, Kim HJ, Lee K, McPherson JD, Hudson TJ; HALT Pan-Leukemia Gene Panel Consortium; Brown AM, Yousif F, Trinh QM, Stein LD, Minden MD, Wang JC, Dick JE. Identification of pre-leukaemic haematopoietic stem cells in acute leukaemia. Nature. 2014 Feb 20;506(7488):328-33. doi: 10.1038/nature13038. Epub 2014 Feb 12.'}, {'pmid': '28446434', 'type': 'BACKGROUND', 'citation': 'Gibson CJ, Kennedy JA, Nikiforow S, Kuo FC, Alyea EP, Ho V, Ritz J, Soiffer R, Antin JH, Lindsley RC. Donor-engrafted CHIP is common among stem cell transplant recipients with unexplained cytopenias. Blood. 2017 Jul 6;130(1):91-94. doi: 10.1182/blood-2017-01-764951. Epub 2017 Apr 26.'}, {'pmid': '30403573', 'type': 'BACKGROUND', 'citation': 'Frick M, Chan W, Arends CM, Hablesreiter R, Halik A, Heuser M, Michonneau D, Blau O, Hoyer K, Christen F, Galan-Sousa J, Noerenberg D, Wais V, Stadler M, Yoshida K, Schetelig J, Schuler E, Thol F, Clappier E, Christopeit M, Ayuk F, Bornhauser M, Blau IW, Ogawa S, Zemojtel T, Gerbitz A, Wagner EM, Spriewald BM, Schrezenmeier H, Kuchenbauer F, Kobbe G, Wiesneth M, Koldehoff M, Socie G, Kroeger N, Bullinger L, Thiede C, Damm F. Role of Donor Clonal Hematopoiesis in Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2019 Feb 10;37(5):375-385. doi: 10.1200/JCO.2018.79.2184. Epub 2018 Nov 7.'}, {'pmid': '31941826', 'type': 'BACKGROUND', 'citation': 'Wong WH, Bhatt S, Trinkaus K, Pusic I, Elliott K, Mahajan N, Wan F, Switzer GE, Confer DL, DiPersio J, Pulsipher MA, Shah NN, Sees J, Bystry A, Blundell JR, Shaw BE, Druley TE. Engraftment of rare, pathogenic donor hematopoietic mutations in unrelated hematopoietic stem cell transplantation. Sci Transl Med. 2020 Jan 15;12(526):eaax6249. doi: 10.1126/scitranslmed.aax6249.'}]}, 'descriptionModule': {'briefSummary': 'Current data on the impact of donor CHIP on long-term recipient outcome remain largely speculative. Data on the impact of donor CHIP including on allograft function, immunologic dysfunction, graft versus host disease (GVHD), disease relapse and survival across various donor populations are scarce. This is a retrospective-prospective cohort study designed to determine the association between donor gene mutations and outcome following allogeneic HSCT.', 'detailedDescription': 'This is a single centre prospective and retrospective cohort study. This study involves allo-HSCT recipients and their donors at Queen Mary Hospital, Hong Kong. Information on the presence of gene mutations in donor peripheral blood or bone marrow sample; gene mutations in recipient peripheral blood or bone marrow post-allo-HSCT; and donor and recipient outcome will be collected in either prospective, partial-prospective/retrospective or retrospective manner. The information will be used to determine the association between the presence of clonal haematopoiesis in the donor and recipient outcome following allo-HSCT.\n\nData will be collected through routine clinical visits and/or reviewing medical records. Data will be collected at the time of peripheral blood stem cells (PBSC) or bone marrow stem cells donation, at the time of allo-HSCT, one month post-allo-HSCT and every 6 months thereafter until death/study termination.\n\nGenetic profile of donors will be collected at the time of PBSC or BM stem cell donation. Genetic profile of recipients will be collected at 1-month, 6-month, 12-month post-HSCT and at time of relapse or occurrence of leukaemia.\n\nGene mutations and pathogenic gene fusion will be determined in the peripheral blood and/or marrow samples by next-generation sequencing (NGS) using a myeloid-gene panel and nanopore long-read sequencing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will involve allo-HSCT recipients and their donors at Queen Mary Hospital, Hong Kong. Information on the presence of gene mutations in donor peripheral blood or bone marrow sample; gene mutations in recipient peripheral blood or bone marrow post-allo-HSCT; and donor and recipient outcome will be collected in either prospective, partial-prospective/retrospective or retrospective manner.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult aged 18 year or above\n2. Donor and recipient of allo-HSCT\n3. In prospective and partial prospective/retrospective case, subjects who have provided a signed written informed consent. In retrospective case, subjects who had provided a previously signed written informed consent on:\n\n 1. voluntary provision of clinical data, and\n 2. voluntary provision of archived/remaining specimens for genetic analysis, and\n 3. authorizing storage and usage of archived/remaining specimens for any further analysis\n\nExclusion Criteria:\n\n1\\. Autologous peripheral blood stem cells or bone marrow stem cell donors for autologous HSCT'}, 'identificationModule': {'nctId': 'NCT04689750', 'briefTitle': 'Donor CHIP and Allogeneic HSCT Outcome', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Impact of Donor Clonal Haematopoiesis of Indeterminate Potential (CHIP) on Recipient Outcome Following Allogeneic Haematopoietic Stem Cell Transplantation (Allo-HSCT)', 'orgStudyIdInfo': {'id': 'CHIP001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Allogeneic HSCT recipients and donors', 'interventionNames': ['Diagnostic Test: Next generation sequencing']}], 'interventions': [{'name': 'Next generation sequencing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Genetic profile of donors will be collected at the time of PBSC or BM stem cell donation. Genetic profile of recipients will be collected at 1-month, 6-month, 12-month post-HSCT and at time of relapse or occurrence of leukaemia.\n\nGene mutations and pathogenic gene fusion will be determined in the peripheral blood and/or marrow samples by next-generation sequencing (NGS) using a myeloid-gene panel and nanopore long-read sequencing.', 'armGroupLabels': ['Allogeneic HSCT recipients and donors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Harinder Gill, MD', 'role': 'CONTACT', 'email': 'gillhsh@hku.hk', 'phone': '85222554542'}, {'name': 'Yok-Lam Kwong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Harinder Gill, MD', 'role': 'CONTACT', 'email': 'gillhsh@hku.hk', 'phone': '+852 22554542'}], 'overallOfficials': [{'name': 'Harinder Gill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}