Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT05272293
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2022-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells 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': '2022-02-28', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)', 'timeFrame': '30 days after every a course of NK immunotherapy', 'description': 'The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR) as measured by response criteria definitions for acute myeloid leukemia.'}, {'measure': 'Leukemia-free survival (LFS)', 'timeFrame': '1 year', 'description': 'Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '1 year', 'description': 'The proportion of patients with overall survival'}], 'secondaryOutcomes': [{'measure': 'Duration of persistence of infused 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': '30 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 for children/young adults with primary high risk or refractory AML and relapsed 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.\n\nFor patients with high-risk primary AML a cycle of immunotherapy includes chemotherapy (HD-ARA-C+IDA) followed by three doses of NK cells infusion.\n\nFor patients with refractory/relapsed AML a cycle of immunotherapy includes chemotherapy (FLAG - fludarabine, cytarabine, G-CSF) followed by three doses of NK cells infusion.\n\nA 2nd cycle of therapy may be administered if a recipient continues to meet the eligibility criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* primary high risk AML\n* primary refractory AML\n* relapsed AML\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': 'NCT05272293', 'briefTitle': 'Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells 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 for Children/Young Adults With High-risk, Refractory or Relapsed AML', 'orgStudyIdInfo': {'id': 'haploNK_ HR/R/R_AML'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'expanded haploidentical NK cell immunotherapy', 'description': 'After a cycle of chemotherapy a patient receive three intravenous infusions of expanded haploidentical NK cells.', 'interventionNames': ['Biological: NK cell infusions']}], 'interventions': [{'name': 'NK cell infusions', 'type': 'BIOLOGICAL', 'description': 'Three 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': 'Mariya Naumovich', 'role': 'CONTACT', 'email': 'mariyanaumovich@gmail.com', 'phone': '+375293563846'}, {'name': 'Olga Aleinikova, MD, Prof', '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'}}}}