Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-30 @ 7:18 AM
Study NCT ID:
NCT05863234
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2023-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054066', 'term': 'Leukemia, Large Granular Lymphocytic'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D015458', 'term': 'Leukemia, T-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2023-05-09', 'studyFirstSubmitQcDate': '2023-05-09', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the first course)', 'timeFrame': '7days after the administration', 'description': 'In order to evaluate tolerability and safety of PPMX-T003 repeated continuous intravenous administration in the first course, incidence of AEs and DLTs by the treatment are measured.'}], 'secondaryOutcomes': [{'measure': 'Number of incidence of AEs and DLTs by PPMX-T003 repeated continuous intravenous administration (the second course or later)', 'timeFrame': 'From the second course to the final course (Max. 35days after the first administration)', 'description': 'In order to evaluate tolerability and safety of PPMX-T003 repeated continuous intravenous administration in the second course or later, incidence of AEs and DLTs by the treatment are measured.'}, {'measure': 'Efficacy of PPMX-T003 repeated continuous intravenous administration (1) Liver volume evaluated by CT scan', 'timeFrame': '35 days', 'description': 'As a part of efficacy evaluation of the treatment, percentage change in the product of the maximum long and short diameters of the liver measured by CT (assessed by the primary physician)'}, {'measure': 'Efficacy of PPMX-T003 repeated continuous intravenous administration (2) improvement in liver function as assessed by the Model for End-stage Liver Disease (MELD and MELD-Na)', 'timeFrame': '35 days'}, {'measure': 'Efficacy of PPMX-T003 repeated continuous intravenous administration (3) Survival duration at 6 months', 'timeFrame': '6 months'}, {'measure': 'Efficacy of PPMX-T003 repeated continuous intravenous administration (4) Percentage of subjects who were able to transition to chemotherapy', 'timeFrame': '35days after the treatment'}, {'measure': 'Serum drug concentration during repeated continuous intravenous PPMX-T003 administration', 'timeFrame': '35 days'}, {'measure': 'Anti-drug antibody production (Immunogenicity)', 'timeFrame': '35 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neoplasms'], 'conditions': ['Aggressive NK Cell Leukemia']}, 'referencesModule': {'references': [{'pmid': '40588385', 'type': 'DERIVED', 'citation': 'Fukuhara N, Onizuka M, Kanda J, Asada N, Kato K, Ando K. Protocol for a multicentre, open-label, dose-escalation phase I/II study evaluating the tolerability, safety, efficacy and pharmacokinetics of repeated continuous intravenous PPMX-T003 in patients with aggressive natural killer cell leukaemia. BMJ Open. 2025 Jun 30;15(6):e098532. doi: 10.1136/bmjopen-2024-098532.'}]}, 'descriptionModule': {'briefSummary': 'This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria.\n\nExclusion Criteria:\n\n* Patients eligible to receive chemotherapy as treatment for ANKL'}, 'identificationModule': {'nctId': 'NCT05863234', 'briefTitle': 'Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Hiroshima University Hospital'}, 'officialTitle': 'Multicenter, Open-label, Dose-escalation Phase I/II Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)', 'orgStudyIdInfo': {'id': 'PPMX-T003-CT103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment with PPMX-T003', 'interventionNames': ['Drug: PPMX-T003']}], 'interventions': [{'name': 'PPMX-T003', 'type': 'DRUG', 'description': 'The therapeutic agent is administered continuously intravenously', 'armGroupLabels': ['Treatment with PPMX-T003']}]}, 'contactsLocationsModule': {'locations': [{'zip': '734-8551', 'city': 'Hiroshima', 'state': 'Hiroshima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kiyoshi Ando', 'role': 'CONTACT', 'email': 'andok@keyaki.cc.u-tokai.ac.jp', 'phone': '+81 82-257-5555'}], 'facility': 'Hiroshima University Hospital', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}], 'centralContacts': [{'name': 'Kiyoshi Ando', 'role': 'CONTACT', 'email': 'andok@keyaki.cc.u-tokai.ac.jp', 'phone': '+81 82-257-5555'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiroshima University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kyoto University Hospital', 'class': 'OTHER'}, {'name': 'Hokkaido University Hospital', 'class': 'OTHER'}, {'name': 'Okayama University', 'class': 'OTHER'}, {'name': 'Tokai University', 'class': 'OTHER'}, {'name': 'Kyushu University', 'class': 'OTHER'}, {'name': 'Tohoku University', 'class': 'OTHER'}, {'name': 'Nagoya University', 'class': 'OTHER'}, {'name': 'Komagome Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}