Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-05 @ 6:03 PM
Study NCT ID:
NCT03300492
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2017-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, single center, open-label, single arm study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2017-07-30', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events including GvHD and infections.', 'timeFrame': '1 year following haplo HSCT', 'description': 'As defined by the CTCAE version 4.03 and the NIH Scoring of GvHD.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '1 year following haplo HSCT'}, {'measure': 'Incidence of AML/MDS-EB complete morphological and molecular remission (CR) at day + 30, + 90, +180 and 1 year post allo-HSCT', 'timeFrame': '1 year following haplo HSCT', 'description': 'rejection.'}, {'measure': 'Incidence of graft rejection', 'timeFrame': '1 year following haplo HSCT'}, {'measure': 'Number of NK cells given per kg body weight', 'timeFrame': '30 days following haplo-HSCT'}, {'measure': 'Number of NK-DLI infusions applied', 'timeFrame': '30 days following haplo-HSCT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Natural Killer cells', 'NK cells', 'Immunotherapy', 'haploidentical hematopoietic stem cell transplantation'], 'conditions': ['Acute Myeloid Leukemia', 'Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'The study examines the application of expanded natural killer cells (NK cells) following haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) for AML or MDS. Haplo-HSCT is a preferred treatment option for patients with AML or MDS without a HLA-matched donor. With administration of cyclophosphamide post-transplant , the safety of the procedure is similar to a HSCT from a HLA-identical donor. Relapse of AML/MDS represents a serious problem following haplo-HSCT. NK cells are immune cells able to destroy tumor cells. Their potency has been established particularly in the setting of a haplo-HSCT. In the current study, study participants undergoing haplo-HSCT will receive expanded NK cells from their respective stem-cell donors following haplo-HSCT. The primary goal of the study is to establish the safety and feasibility of this approach. In addition, the activity of the NK cells will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatient:\n\n* \\>18 years of age\n* No HLA-matched related or unrelated donor available\n* AML or MDS-EB with indication for a haplo-HSCT according to the guidelines of the University Hospital Basel Stem Cell Transplant Team\n* Judged by the transplant physicians to have adequate organ function and no contraindications to haplo-HSCT\n* Available related haploidentical donor\n* Written informed consent\n\nDonor:\n\n* \\>18 years old, haploidentical parent, sibling or other relative\n* Donor suitable for cell donation and apheresis according to standard criteria\n* Written informed consent\n\nExclusion Criteria:\n\nPatient:\n\n* APL diagnosis\n* Presence of relevant (mean fluorescence intensity \\>2000) donor-specific anti-HLA antibodies\n* Pregnancy\n* Necessity of immunosuppression apart from GvHD prophylaxis\n\nExclusion Criteria:\n\nDonor:\n\n• Pregnancy'}, 'identificationModule': {'nctId': 'NCT03300492', 'briefTitle': 'Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'A Phase I/II Single Center Study to Assess the Safety, Tolerability and Feasibility of Pre-emptive Immunotherapy With in Vitro Expanded Natural Killer Cells in Patients Treated With Haplo-HSCT for AML/MDS', 'orgStudyIdInfo': {'id': 'Haplo-NK-DLI for AML/MDS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NK-DLI', 'description': 'Preemptive immunotherapy with ex vivo expanded NK cells on days\n\n+10, +15 and +20 with increasing NK cell doses following haplo-HSCT.', 'interventionNames': ['Other: NK-DLI']}], 'interventions': [{'name': 'NK-DLI', 'type': 'OTHER', 'description': 'Application of three infusions of ex vivo expanded NK cells on days\n\n+10, +15 and +20 with increasing NK cell doses (1x107/kg, 1x108/kg and the remaining cells up to 1x109/kg) following haplo-HSCT. Maximal cumulative T-cell dose is fixed at \\<1x105/kg.', 'armGroupLabels': ['NK-DLI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Matyas Ecsedi, MD-PhD', 'role': 'CONTACT', 'email': 'matyas.ecsedi@usb.ch', 'phone': '+41612652525'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Matyas Ecsedi, MD-PhD', 'role': 'CONTACT', 'email': 'matyas.ecsedi@usb.ch', 'phone': '+41612652525'}], 'overallOfficials': [{'name': 'Jakob Passweg, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Basel Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}