Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT02229266
Status:
TERMINATED
Last Update Posted:
2021-08-16
First Post:
2014-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'low recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-04-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-10', 'studyFirstSubmitDate': '2014-08-28', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year overall survival', 'timeFrame': '2 years after study inclusion', 'description': 'measure time of survival of each patiente up to 2 years after study inclusion'}], 'secondaryOutcomes': [{'measure': 'Time to relapse', 'timeFrame': '2 years after study inclusion', 'description': 'evaluate time to relapse for 2 years after study inclusion for each patient; calculate cumulative incidence of relapse'}, {'measure': 'Relapse-free survival', 'timeFrame': '2 years after study inclusion'}, {'measure': 'Yield and purity of NK cells (CD3-CD56+) after CD3 depletion and CD56 enrichment', 'timeFrame': 'timepoint of application of NK cells'}, {'measure': 'NK cell analysis', 'timeFrame': '2 years after study inclusion'}, {'measure': 'Clinical performance (ECOG score)', 'timeFrame': '2 years after study inclusion'}, {'measure': 'Incidence and severity of GVHD', 'timeFrame': '6 months after start of treatment'}, {'measure': 'Incidence of (S)AEs', 'timeFrame': '5 weeks after start of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AML', 'high-risk AML', 'acute myeloid leukemia', 'NK cells', 'haploidentical natural killer cells', 'immunotherapy'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sal-aml.org', 'label': 'Study Alliance Leukemia'}, {'url': 'http://www.uniklinikum-dresden.de/das-klinikum/kliniken-polikliniken-institute/mk1', 'label': 'Universitätsklinikum Dresden, Medizinische Klinik I'}]}, 'descriptionModule': {'briefSummary': 'The trial investigates the efficacy of adoptive immunotherapy with haploidentical natural killer cells compared to standard chemotherapy (after first complete remission) in patients with a high-risk acute myeloid leukemia being older than 65 years of age and not eligible for allogeneic transplantation', 'detailedDescription': 'Randomised controlled phase-2 trial to determine the efficacy of adoptive immunotherapy with haploidentical natural killer cells in high-risk acute myeloid leukemia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria\n* In AML defined by cytogenetic aberrations the proportion of blasts may be \\<20%\n* Age ≥60 years\n* Clinical performance corresponding to ECOG score 0-2\n* High-risk karyotype\n* \\<5% myeloblasts in bone marrow ≥21 days after beginning of most recent chemotherapy\n* maximal two preceding chemotherapy cycles\n* Potentially available haploidentical family donor (child/ sibling), willing and fit for NK cell donation\n\nExclusion Criteria:\n\n* AML with favorable or intermediate risk cytogenetic features\n* Persistent aplasia following preceding chemotherapy\n* Relapsed or refractory AML\n* Known pre-existing autoimmune diseases\n* Any severe concomitant condition which makes it undesirable for the patient to participate in the study\n* Any condition which could jeorpadize compliance of the protocol\n* Participation in another clinical trial during or within 4 weeks before study entry'}, 'identificationModule': {'nctId': 'NCT02229266', 'acronym': 'HINKL', 'briefTitle': 'Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With Haploidentical Natural Killer Cells in High-risk Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'TUD-HINKL1-059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NK cells', 'description': 'Infusion of haploidentical NK cells after immunosuppression with cyclophosphamide and fludarabine, followed by immunostimulatory treatment with interleukin-2', 'interventionNames': ['Biological: NK cells']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Intervention', 'description': '1 cycle of consolidation chemotherapy with high-dose cytarabine', 'interventionNames': ['Drug: Cytarabine']}], 'interventions': [{'name': 'NK cells', 'type': 'BIOLOGICAL', 'otherNames': ['CD3-negative/ CD56-positive NK cells from HLA-haploidentical family', 'donors'], 'armGroupLabels': ['NK cells']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['chemotherapy'], 'description': '1 cycle of consolidation chemotherapy with high-dose cytarabine', 'armGroupLabels': ['Control Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bayreuth', 'country': 'Germany', 'facility': 'Klinikum Bayreuth', 'geoPoint': {'lat': 49.94782, 'lon': 11.57893}}, {'city': 'Chemnitz', 'country': 'Germany', 'facility': 'Klinikum Chemnitz', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Martin Bornhäuser, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Dresden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}