Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05334693
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2022-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-04-12', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse-free survival (RFS)', 'timeFrame': '2 years', 'description': 'Time from achievement of CR to the time of relapse or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'The proportion of patients with overall survival'}], 'secondaryOutcomes': [{'measure': 'Persistence of donor NK cells', 'timeFrame': '21 days after the first infusion', 'description': 'Days of persistence of donor NK cells'}, {'measure': 'Number of T, B, NK, activated T and NK cells after immunotherapy', 'timeFrame': '28 days after the first infusion', 'description': 'Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Natural killer cells', 'Immunotherapy'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.', 'detailedDescription': 'Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* primary intermediate risk AML in molecular complete remission;\n* primary high risk AML in molecular complete remission awaiting unrelated HSCT;\n* Karnofsky or Lansky performance scale greater or equal to 70;\n* written informed consent.\n\nDonors:\n\n* haploidentical family donor;\n* donor suitable for cell donation and apheresis according to standard criteria;\n* written informed consent.\n\nExclusion Criteria:\n\nPatients:\n\n* uncontrolled infection;\n* severe hepatic dysfunction: SGOT or SCPT \\>=5x upper limit of normal for age;\n* positive serology for human immunodeficiency virus (HIV).\n\nDonors:\n\n* pregnancy;\n* positive serology for HIV, hepatitis B or C.'}, 'identificationModule': {'nctId': 'NCT05334693', 'briefTitle': 'Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML', 'organization': {'class': 'OTHER', 'fullName': 'Belarusian Research Center for Pediatric Oncology, Hematology and Immunology'}, 'officialTitle': 'Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML', 'orgStudyIdInfo': {'id': 'HaploNK_consolidation_AML'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expanded haploidentical NK cell immunotherapy', 'description': 'After a lymphodepleting chemotherapy a patient receive two intravenous infusions of expanded haploidentical NK cells.', 'interventionNames': ['Biological: Expanded haploidentical NK cells']}], 'interventions': [{'name': 'Expanded haploidentical NK cells', 'type': 'BIOLOGICAL', 'description': 'Two doses of expanded haploidentical NK cells (30-100 x 10\\^6 cells /kg).', 'armGroupLabels': ['Expanded haploidentical NK cell immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223053', 'city': 'Minsk', 'state': 'Minsk Oblast', 'status': 'RECRUITING', 'country': 'Belarus', 'contacts': [{'name': 'Tatsiana Shman', 'role': 'CONTACT', 'email': 'shman@oncology.by', 'phone': '+37529 6341853'}, {'name': 'Olga Aleinikova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Belarussian Research Center for Pediatric Oncology, Hematology and Immunology'}], 'centralContacts': [{'name': 'Tatsiana Shman, PhD', 'role': 'CONTACT', 'email': 'shman@oncology.by', 'phone': '+375296341853'}, {'name': 'Mariya Naumovich, MD', 'role': 'CONTACT', 'email': 'mariyanaumovich@gmail.com', 'phone': '+375293563846'}], 'overallOfficials': [{'name': 'Olga Aleinikova, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Belarussian Research Center for Pediatric Oncology, Hematology and Immunology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Belarusian Research Center for Pediatric Oncology, Hematology and Immunology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}