Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-03 @ 8:27 AM
Study NCT ID:
NCT06717958
Status:
RECRUITING
Last Update Posted:
2025-07-02
First Post:
2024-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation
Sponsor:
Organization:
Raw JSON
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'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2024-11-27', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'event-free survival', 'timeFrame': '24 months'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AML', 'MDS']}, 'descriptionModule': {'briefSummary': 'maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days', 'detailedDescription': 'Determination of the efficacy of Ivosidenib to improve event-free survival when given as maintenance therapy following alloSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criterion:\n\n* AML or MDS with IDH1 mutation\n\nExclusion criteria:\n\n* active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids \\>1mg/ kg prednisolone equivalent'}, 'identificationModule': {'nctId': 'NCT06717958', 'acronym': 'PIVOT', 'briefTitle': 'Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'A Prospective, Single-arm, Open-label, Multicenter Phase II Trial Evaluating the Efficacy and Safety of Ivosidenib Maintenance Therapy After Allogeneic Stem Cell Transplantation (alloSCT) in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Neoplasia (MD) Carrying an IDH1 Mutation', 'orgStudyIdInfo': {'id': 'TUD-PIVOT1-085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ivosidenib', 'interventionNames': ['Drug: Ivosidenib 250 MG (milligram)']}], 'interventions': [{'name': 'Ivosidenib 250 MG (milligram)', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Ivosidenib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aachen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Edgar Jost', 'role': 'CONTACT', 'email': 'info@ukaachen.de', 'phone': '+49241800'}], 'facility': 'Universitätsklinikum Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Dresden', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jan Moritz Middeke, Dr. med.', 'role': 'CONTACT', 'email': 'pivot@ukdd.de', 'phone': '+493514583192'}], 'facility': 'Technische Universitaet Dresden, Medizinische Klinik und Poliklinik I', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Essen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Schroeder, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'studienzentrum-haemaSZT@uk-essen.de', 'phone': '+492017231861'}], 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Lutz Peter Müller, Prof.', 'role': 'CONTACT', 'email': 'innere4@uk-halle.de', 'phone': '+493455572924'}], 'facility': 'Martin-Luther-Universitaet Halle-Wittenberg', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Hamburg', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Evgeny Klyuchnikov, Dr. med.', 'role': 'CONTACT', 'email': 'info@uke.de', 'phone': '+494074100'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Jena', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Inken Hilgendorf, Apl. Prof. Dr. med.', 'role': 'CONTACT', 'email': 'onkologie@med.uni-jena.de', 'phone': '+4936419324201'}], 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'Kiel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Anca-Maria Albici, Dr. med.', 'role': 'CONTACT', 'email': 'Anca-Maria.Albici@uksh.de', 'phone': '+4943150022501'}], 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Leipzig', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Barbara Jentzsch, PD Dr. med.', 'role': 'CONTACT', 'email': 'Haematologie.Studieneinheit@medizin.uni-leipzig.de', 'phone': '+4934197109'}], 'facility': 'Universität Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'München', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Mareike Verbeek, Dr. med.', 'role': 'CONTACT', 'email': 'Sandra.Eckert@mri.tum.de', 'phone': '+49 8941405736'}], 'facility': 'Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Münster', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Stelljes, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'kmt@ukmuenster.de', 'phone': '+492518352801'}], 'facility': 'Universität Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Rostock', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Johannes Lakner', 'role': 'CONTACT', 'email': 'onkologie@med.uni-rostock.de', 'phone': '+493814947459'}], 'facility': 'Rostock University Medical Center', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'city': 'Ulm', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Elisa Sala, Dr. med.', 'role': 'CONTACT', 'email': 'Elisa.Sala@uniklinik-ulm.de', 'phone': '+4973150045501'}], 'facility': 'Universitaetsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Jan Moritz Middeke, Dr. med.', 'role': 'CONTACT', 'email': 'pivot@ukdd.de', 'phone': '+493514583192'}, {'name': 'Friedrich Stölzel, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'pivot@ukdd.de', 'phone': '+493514583192'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}