[{"id":"e5e2b950-7554-4958-b2db-713f66c51761","acronym":"","url":"https://clinicaltrials.gov/study/NCT03280030","created_at":"2021-01-18T16:11:51.281Z","updated_at":"2025-02-25T15:42:59.213Z","phase":"Phase 2","brief_title":"A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML","source_id_and_acronym":"NCT03280030","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" FLT3 • PML","pipe":" | ","alterations":" FLT3 mutation","tags":["FLT3 • PML"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • midostaurin • daunorubicin"],"overall_status":"Completed","enrollment":" Enrollment 67","initiation":"Initiation: 04/06/2018","start_date":" 04/06/2018","primary_txt":" Primary completion: 11/14/2022","primary_completion_date":" 11/14/2022","study_txt":" Completion: 11/14/2022","study_completion_date":" 11/14/2022","last_update_posted":"2025-02-11"},{"id":"b4e91c3d-4887-4ce6-b858-890536bcbb7b","acronym":"HOVON 156 AML","url":"https://clinicaltrials.gov/study/NCT04027309","created_at":"2021-01-18T19:46:07.637Z","updated_at":"2025-02-25T15:26:07.674Z","phase":"Phase 3","brief_title":"A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy","source_id_and_acronym":"NCT04027309 - HOVON 156 AML","lead_sponsor":"Stichting Hemato-Oncologie voor Volwassenen Nederland","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 mutation • FLT3-TKD mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 mutation • FLT3-TKD mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Xospata (gilteritinib) • midostaurin"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 777","initiation":"Initiation: 12/20/2019","start_date":" 12/20/2019","primary_txt":" Primary completion: 10/01/2025","primary_completion_date":" 10/01/2025","study_txt":" Completion: 06/01/2033","study_completion_date":" 06/01/2033","last_update_posted":"2024-12-17"},{"id":"d2f2a1f1-7bb1-4919-a610-7815b806ac30","acronym":"NCI-2019-01726","url":"https://clinicaltrials.gov/study/NCT03900949","created_at":"2021-01-18T19:12:29.931Z","updated_at":"2024-07-02T16:35:01.958Z","phase":"Phase 1","brief_title":"Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia","source_id_and_acronym":"NCT03900949 - NCI-2019-01726","lead_sponsor":"Uma Borate","biomarkers":" FLT3 • CD33","pipe":" | ","alterations":" CD33 positive • CD33 expression","tags":["FLT3 • CD33"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CD33 positive • CD33 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • midostaurin • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Starasid (cytarabine ocfosfate)"],"overall_status":"Suspended","enrollment":" Enrollment 18","initiation":"Initiation: 03/13/2019","start_date":" 03/13/2019","primary_txt":" Primary completion: 01/01/2025","primary_completion_date":" 01/01/2025","study_txt":" Completion: 01/01/2025","study_completion_date":" 01/01/2025","last_update_posted":"2024-05-22"},{"id":"29adfbf7-ec59-401a-b21b-e4307b0a528a","acronym":"","url":"https://clinicaltrials.gov/study/NCT03591510","created_at":"2021-01-18T17:39:51.327Z","updated_at":"2024-07-02T16:35:11.198Z","phase":"Phase 2","brief_title":"A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML","source_id_and_acronym":"NCT03591510","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3 mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • etoposide IV • midostaurin • daunorubicin • idarubicin hydrochloride • mitoxantrone • fludarabine IV"],"overall_status":"Recruiting","enrollment":" Enrollment 23","initiation":"Initiation: 03/13/2019","start_date":" 03/13/2019","primary_txt":" Primary completion: 08/18/2025","primary_completion_date":" 08/18/2025","study_txt":" Completion: 02/15/2029","study_completion_date":" 02/15/2029","last_update_posted":"2024-04-05"},{"id":"fe2e9c02-b568-4273-9f6b-89146f4af44d","acronym":"","url":"https://clinicaltrials.gov/study/NCT02756962","created_at":"2021-01-18T13:30:57.647Z","updated_at":"2024-07-02T16:35:12.037Z","phase":"Phase 2","brief_title":"Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance","source_id_and_acronym":"NCT02756962","lead_sponsor":"Washington University School of Medicine","biomarkers":" FLT3 • NPM1 • CEBPA","pipe":" | ","alterations":" FLT3-ITD mutation • NPM1 mutation • CEBPA mutation","tags":["FLT3 • NPM1 • CEBPA"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • NPM1 mutation • CEBPA mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • midostaurin"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 107","initiation":"Initiation: 07/06/2016","start_date":" 07/06/2016","primary_txt":" Primary completion: 07/31/2033","primary_completion_date":" 07/31/2033","study_txt":" Completion: 07/31/2033","study_completion_date":" 07/31/2033","last_update_posted":"2024-04-02"},{"id":"e5940e7b-30fd-4553-89ee-3676c7d30b8b","acronym":"A2408","url":"https://clinicaltrials.gov/study/NCT03379727","created_at":"2021-01-17T17:21:47.746Z","updated_at":"2024-07-02T16:35:17.043Z","phase":"Phase 3","brief_title":"Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia.","source_id_and_acronym":"NCT03379727 - 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PrE0905","lead_sponsor":"PrECOG, LLC.","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • Xospata (gilteritinib) • midostaurin • daunorubicin"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 181","initiation":"Initiation: 12/06/2019","start_date":" 12/06/2019","primary_txt":" Primary completion: 10/17/2023","primary_completion_date":" 10/17/2023","study_txt":" Completion: 12/01/2024","study_completion_date":" 12/01/2024","last_update_posted":"2024-02-22"},{"id":"83b190e4-8016-487a-a46f-704af274a7d3","acronym":"AML-VAC-XS15","url":"https://clinicaltrials.gov/study/NCT06252584","created_at":"2024-02-09T21:21:45.319Z","updated_at":"2024-07-02T16:35:19.957Z","phase":"Phase 1","brief_title":"Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia Patients","source_id_and_acronym":"NCT06252584 - AML-VAC-XS15","lead_sponsor":"University Hospital Tuebingen","biomarkers":" IFNG","pipe":"","alterations":" ","tags":["IFNG"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e azacitidine • midostaurin"],"overall_status":"Not yet recruiting","enrollment":" Enrollment 20","initiation":"Initiation: 05/02/2024","start_date":" 05/02/2024","primary_txt":" Primary completion: 05/02/2026","primary_completion_date":" 05/02/2026","study_txt":" Completion: 11/02/2026","study_completion_date":" 11/02/2026","last_update_posted":"2024-02-09"},{"id":"5304aded-adbc-4379-a969-3514dee4dfa6","acronym":"","url":"https://clinicaltrials.gov/study/NCT03092674","created_at":"2023-11-14T02:14:22.100Z","updated_at":"2024-07-02T16:35:29.609Z","phase":"Phase 2/3","brief_title":"Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","source_id_and_acronym":"NCT03092674","lead_sponsor":"National Cancer Institute (NCI)","biomarkers":" FLT3","pipe":"","alterations":" ","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e Opdivo (nivolumab) • cytarabine • azacitidine • midostaurin • decitabine • ABP 206 (nivolumab biosimilar) • Starasid (cytarabine ocfosfate)"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 78","initiation":"Initiation: 02/02/2018","start_date":" 02/02/2018","primary_txt":" Primary completion: 08/01/2023","primary_completion_date":" 08/01/2023","study_txt":" Completion: 10/29/2024","study_completion_date":" 10/29/2024","last_update_posted":"2023-11-10"},{"id":"192b121c-dfa2-4eff-ae2b-d136c65ef93b","acronym":" UNIFY","url":"https://clinicaltrials.gov/study/NCT03512197","created_at":"2021-01-18T17:17:13.296Z","updated_at":"2024-07-02T16:35:39.473Z","phase":"Phase 3","brief_title":"A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)","source_id_and_acronym":"NCT03512197 - 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MOSAIC","lead_sponsor":"Technische Universität Dresden","biomarkers":" FLT3 • RUNX1 • RUNX1T1","pipe":" | ","alterations":" CD33 expression","tags":["FLT3 • RUNX1 • RUNX1T1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e CD33 expression"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • midostaurin • Mylotarg (gemtuzumab ozogamicin) • daunorubicin"],"overall_status":"Recruiting","enrollment":" Enrollment 214","initiation":"Initiation: 09/04/2020","start_date":" 09/04/2020","primary_txt":" Primary completion: 04/01/2027","primary_completion_date":" 04/01/2027","study_txt":" Completion: 04/01/2028","study_completion_date":" 04/01/2028","last_update_posted":"2023-08-09"},{"id":"d55206d4-5661-49dc-a57d-bdc2a55f29f9","acronym":"","url":"https://clinicaltrials.gov/study/NCT01093573","created_at":"2021-01-18T04:19:18.660Z","updated_at":"2024-07-02T16:36:08.035Z","phase":"Phase 1/2","brief_title":"Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia","source_id_and_acronym":"NCT01093573","lead_sponsor":"Brenda Cooper, MD","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3 mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e azacitidine • midostaurin"],"overall_status":"Completed","enrollment":" Enrollment 34","initiation":"Initiation: 07/01/2009","start_date":" 07/01/2009","primary_txt":" Primary completion: 09/08/2016","primary_completion_date":" 09/08/2016","study_txt":" Completion: 05/05/2017","study_completion_date":" 05/05/2017","last_update_posted":"2022-06-30"},{"id":"9ec918d6-6c66-45cd-b449-933f7666cefc","acronym":"Q-SOC","url":"https://clinicaltrials.gov/study/NCT04676243","created_at":"2021-07-12T07:53:02.092Z","updated_at":"2024-07-02T16:36:09.925Z","phase":"Phase 3","brief_title":"Daunorubicin or Idarubicin With Cytarabine Plus Quizartinib vs Physician's Choice in Newly Diagnosed FLT3-ITD+ AML","source_id_and_acronym":"NCT04676243 - Q-SOC","lead_sponsor":"University Hospital Heidelberg","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 wild-type","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 wild-type"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • midostaurin • Vanflyta (quizartinib) • daunorubicin • idarubicin hydrochloride"],"overall_status":"Withdrawn","enrollment":"","initiation":"Initiation: 05/01/2022","start_date":" 05/01/2022","primary_txt":" Primary completion: 05/01/2025","primary_completion_date":" 05/01/2025","study_txt":" Completion: 12/01/2025","study_completion_date":" 12/01/2025","last_update_posted":"2022-05-25"},{"id":"6bce8e14-7bf7-49d3-9127-af624fb0f8a5","acronym":"AMELIORATE","url":"https://clinicaltrials.gov/study/NCT04174612","created_at":"2021-01-18T20:21:50.187Z","updated_at":"2024-07-02T16:36:16.286Z","phase":"Phase 3","brief_title":"AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance","source_id_and_acronym":"NCT04174612 - AMELIORATE","lead_sponsor":"Gruppo Italiano Malattie EMatologiche dell'Adulto","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3 mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • midostaurin • daunorubicin"],"overall_status":"Recruiting","enrollment":" Enrollment 172","initiation":"Initiation: 04/24/2020","start_date":" 04/24/2020","primary_txt":" Primary completion: 12/01/2022","primary_completion_date":" 12/01/2022","study_txt":" Completion: 08/01/2025","study_completion_date":" 08/01/2025","last_update_posted":"2022-03-02"},{"id":"275b6517-77bb-425a-8196-b5780774570e","acronym":"RATIFY","url":"https://clinicaltrials.gov/study/NCT00651261","created_at":"2021-01-17T17:21:46.899Z","updated_at":"2025-02-25T15:49:16.394Z","phase":"Phase 3","brief_title":"Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia","source_id_and_acronym":"NCT00651261 - RATIFY","lead_sponsor":"Alliance for Clinical Trials in Oncology","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3 mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • midostaurin • daunorubicin"],"overall_status":"Active, not recruiting","enrollment":" Enrollment 717","initiation":"Initiation: 04/01/2008","start_date":" 04/01/2008","primary_txt":" Primary completion: 07/01/2016","primary_completion_date":" 07/01/2016","study_txt":"","study_completion_date":"","last_update_posted":"2021-08-18"},{"id":"4aa75a56-5ce2-4044-bf07-825200f7d0c6","acronym":"","url":"https://clinicaltrials.gov/study/NCT01883362","created_at":"2021-01-18T08:26:35.176Z","updated_at":"2024-07-02T16:36:33.209Z","phase":"Phase 2","brief_title":"Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML","source_id_and_acronym":"NCT01883362","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" FLT3 • HLA-DRB1","pipe":" | ","alterations":" FLT3-ITD mutation","tags":["FLT3 • HLA-DRB1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e midostaurin"],"overall_status":"Completed","enrollment":" Enrollment 60","initiation":"Initiation: 02/06/2014","start_date":" 02/06/2014","primary_txt":" Primary completion: 04/30/2018","primary_completion_date":" 04/30/2018","study_txt":" Completion: 04/30/2018","study_completion_date":" 04/30/2018","last_update_posted":"2021-03-17"},{"id":"e2751f23-5c14-4d4f-85a6-803158818aaf","acronym":"","url":"https://clinicaltrials.gov/study/NCT00093600","created_at":"2021-01-18T00:17:10.583Z","updated_at":"2024-07-02T16:36:37.127Z","phase":"Phase 1","brief_title":"PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia","source_id_and_acronym":"NCT00093600","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" FLT3","pipe":" | ","alterations":" FLT3 mutation","tags":["FLT3"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3 mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • midostaurin • daunorubicin"],"overall_status":"Completed","enrollment":" Enrollment 69","initiation":"Initiation: 02/01/2004","start_date":" 02/01/2004","primary_txt":" Primary completion: 06/01/2011","primary_completion_date":" 06/01/2011","study_txt":" Completion: 06/01/2011","study_completion_date":" 06/01/2011","last_update_posted":"2020-12-19"},{"id":"3595892a-b438-47a6-9905-bb90d4dc044d","acronym":"","url":"https://clinicaltrials.gov/study/NCT02078609","created_at":"2021-01-18T09:34:53.711Z","updated_at":"2024-07-02T16:36:37.178Z","phase":"Phase 1","brief_title":"A Safety and Efficacy Study of LGH447 in Patients With Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)","source_id_and_acronym":"NCT02078609","lead_sponsor":"Novartis Pharmaceuticals","biomarkers":" FLT3 • EIF4EBP1","pipe":" | ","alterations":" FLT3-ITD mutation • FLT3 mutation • FLT3 wild-type","tags":["FLT3 • EIF4EBP1"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • FLT3 mutation • FLT3 wild-type"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e midostaurin • PIM447"],"overall_status":"Completed","enrollment":" Enrollment 70","initiation":"Initiation: 03/20/2014","start_date":" 03/20/2014","primary_txt":" Primary completion: 04/18/2019","primary_completion_date":" 04/18/2019","study_txt":" Completion: 04/18/2019","study_completion_date":" 04/18/2019","last_update_posted":"2020-12-17"},{"id":"d054e93b-aa86-4ac4-9492-572f26b073c2","acronym":"MIDOKIT","url":"https://clinicaltrials.gov/study/NCT01830361","created_at":"2021-01-18T08:08:18.537Z","updated_at":"2025-02-25T15:40:47.589Z","phase":"Phase 2","brief_title":"Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML","source_id_and_acronym":"NCT01830361 - MIDOKIT","lead_sponsor":"Technische Universität Dresden","biomarkers":" FLT3 • KIT","pipe":" | ","alterations":" FLT3-ITD mutation • KIT mutation","tags":["FLT3 • KIT"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e FLT3-ITD mutation • KIT mutation"," \u003cb class=\"violet\"\u003e|\u003c/b\u003e cytarabine • midostaurin"],"overall_status":"Completed","enrollment":" Enrollment 18","initiation":"Initiation: 03/13/2013","start_date":" 03/13/2013","primary_txt":" Primary completion: 10/30/2019","primary_completion_date":" 10/30/2019","study_txt":" Completion: 10/30/2019","study_completion_date":" 10/30/2019","last_update_posted":"2020-08-06"},{"id":"446d1230-9ade-4bf1-a7fc-f0b8f0efe84d","acronym":"AMLFLT3","url":"https://clinicaltrials.gov/study/NCT02624570","created_at":"2021-01-18T12:45:15.232Z","updated_at":"2024-07-02T16:36:43.240Z","phase":"","brief_title":"Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy","source_id_and_acronym":"NCT02624570 - 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