Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-26 @ 4:58 PM
Study NCT ID:
NCT06034535
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2023-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 23}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-09-06', 'studyFirstSubmitQcDate': '2023-09-06', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft failure-free, GVHD-free survival', 'timeFrame': 'up to 1 year', 'description': 'From the date of treatment start until the date of graft failure or GVHD or death from any cause, whichever comes first, assessed up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to 1 year', 'description': 'From the date of treatment start until the date of death from any cause, assessed up to 1 year'}, {'measure': 'Proportion of patients who develop relapse among those with malignant diseases', 'timeFrame': 'up to 1 year', 'description': 'Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission'}, {'measure': 'Proportion of patients who develop graft failure', 'timeFrame': 'up to 1 year', 'description': 'Graft failure is defined as donor cells \\<5% in whole blood'}, {'measure': 'Proportion of patients who develop infection', 'timeFrame': 'up to 1 year', 'description': 'Any microbiologically documented infections are included'}, {'measure': 'Proportion of patients who develop acute graft-versus-host disease', 'timeFrame': 'up to 1 year', 'description': 'Acute graft-versus-host disease is defined by MAGIC criteria'}, {'measure': 'Proportion of patients who develop chronic graft-versus-host disease', 'timeFrame': 'up to 1 year', 'description': 'Chronic graft-versus-host disease is defined by NIH criteria'}, {'measure': 'Proportion of patients who develop adverse events not mentioned in outcomes 4-7', 'timeFrame': 'up to 1 year', 'description': 'Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)'}, {'measure': 'Blood T lymphocyte count at 3 months', 'timeFrame': 'at 3 months', 'description': 'Mean T lymphocyte count in blood among evaluable patients'}, {'measure': 'Blood T lymphocyte count at 1 year', 'timeFrame': 'at 1 year', 'description': 'Mean T lymphocyte count in blood among evaluable patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic Organs; Disorder']}, 'descriptionModule': {'briefSummary': 'In this clinical trial, the investigators aim to apply CD62L depleted donor lymphocyte infusion (DLI) together with in vitro T cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) to treat patients with malignant or non-malignant disease in need of HSCT. The investigators shall evaluate the graft failure-free, graft-versus-host disease (GVHD)-free survival at one year, frequency of adverse events and post-transplant complications, and immunoreconstitution.', 'detailedDescription': "The peripheral stem cell harvest product from the patient's related haploidential donor will be divided into two portions. One portion will undergo T cell receptor (TCR) αβ depletion and the other portion will undergo CD62L depletion. Both depleted products will be infused intravenously to the patient on the same day."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who requires allogeneic hematopoietic stem cell transplant, has no human leukocyte antigen (HLA)-matched sibling donor but has an HLA-haploidentical donor.\n* Adequate organ function to tolerate the conditioning chemotherapy and radiotherapy\n* Karnofsky or Lansky performance status score ≥50\n\nExclusion Criteria:\n\n* Pregnant or lactating woman\n* HIV infection\n* Patients for whom alternative treatment is deemed more appropriate by treating physician\n* Patients who are unlikely to benefit from haploidentical hematopoietic stem cell transplantation, e.g., terminal malignancy with multiorgan failure'}, 'identificationModule': {'nctId': 'NCT06034535', 'briefTitle': 'CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': "Hong Kong Children's Hospital"}, 'officialTitle': 'CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'HKCH-REC-2022-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'CD62L depleted donor lymphocyte infusion', 'interventionNames': ['Biological: CD62L depleted donor lymphocyte infusion']}], 'interventions': [{'name': 'CD62L depleted donor lymphocyte infusion', 'type': 'BIOLOGICAL', 'description': 'Intravenous infusion of CD62L depleted donor lymphocytes', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Daniel Cheuk', 'role': 'CONTACT', 'email': 'cheukkld@gmail.com', 'phone': '852-35136049'}], 'facility': "Hong Kong Children's Hospital", 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Daniel Cheuk', 'role': 'CONTACT', 'email': 'cheukkld@gmail.com', 'phone': '85235136049'}], 'overallOfficials': [{'name': 'Daniel Cheuk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hong Kong Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hong Kong Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Cheuk Ka Leung Daniel', 'investigatorAffiliation': "Hong Kong Children's Hospital"}}}}