11 completed, 5 terminated, 4 withdrawn, 2 active not recruiting. 26 Phase 2, 8 Phase 1, 1 Phase 3.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Venetoclax in Association With 3+7 and Midostaurin in FLT3-mutated Acute Myeloid Leukemia Venetoclax in association with 3+7 and midostaurin - Leukemia, Myeloid, Acute | Phase 1 / Phase 2 | Not yet recruiting | University Hospital, Bordeaux | 41 | 2026-09-01 | 2026-07-24 |
| Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia CPX-351, Midostaurin, Busulfan - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Withdrawn | Guenther Koehne | 2022-07-05 | 2024-10-01 | |
| Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC) MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO, MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO, MAGNOLIA-trial: conventional chemotherapy (AraC+DNR)+GO - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Recruiting | Technische Universität Dresden | 214 | 2020-09-04 | 2025-09-08 |
| Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation Midostaurin - Acute Myeloid Leukemia, Adult | Phase 2 | Terminated | University of Jena | 1 | 2020-03-20 | 2022-01-21 |
| Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia Gilteritinib, Midostaurin, Daunorubicin - Acute Myeloid Leukemia | Phase 2 | Completed | PrECOG, LLC. | 181 | 2019-12-06 | 2026-07-23 |
| Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients Decitabine, Midostaurin - AML/MDS | Phase 2 | Active not recruiting | Stichting Hemato-Oncologie voor Volwassenen Nederland | 140 | 2019-12-05 | 2024-09-19 |
| HDM201 Added to CT in R/R or Newly Diagnosed AML HDM201, cytarabine, anthracycline - Leukemia, Myeloid, Acute | Phase 1 / Phase 2 | Withdrawn | Novartis Pharmaceuticals | 2019-11-15 | 2020-01-09 | |
| A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML Midostaurin, Fludarabine, Cytarabine - FLT3-mutated Acute Myeloid Leukemia | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 22 | 2019-03-13 | 2026-07-09 |
| iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004) Midostaurin, Cytarabine - Acute Myeloid Leukemia | Phase 2 | Withdrawn | University of Florida | 2018-11-01 | 2018-10-22 | |
| Midostaurin Associated With Standard Chemotherapy in Patients With Core-binding Factor Leukemia Midostaurin - Core Binding Factor Acute Myeloid Leukemia (CBF-AML) | Phase 2 | Terminated | Niguarda Hospital | 34 | 2018-07-01 | 2025-02-25 |
| A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML Midostaurin, Placebo - Acute Myeloid Leukemia | Phase 2 | Completed | Novartis Pharmaceuticals | 67 | 2018-04-06 | 2025-03-20 |
| 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 Azacitidine, Cytarabine, Decitabine - Acute Myeloid Leukemia, Myelodysplastic Syndrome | Phase 2 / Phase 3 | Completed | National Cancer Institute (NCI) | 76 | 2018-02-02 | 2025-01-16 |
| Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation Decitabine, Laboratory Biomarker Analysis, Midostaurin - Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations | Phase 2 | Terminated | Mayo Clinic | 1 | 2015-12-30 | 2019-08-07 |
| Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia Cladribine, Cytarabine, Gilteritinib - Acute Biphenotypic Leukemia, Acute Myeloid Leukemia | Phase 2 | Recruiting | M.D. Anderson Cancer Center | 508 | 2014-05-19 | 2026-05-20 |
| Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML Midostaurin, Standard of Care - Acute Myeloid Leukemia | Phase 2 | Completed | Novartis Pharmaceuticals | 60 | 2014-02-06 | 2021-03-17 |
| Midostaurin in Indolent Systemic Mastocytosis Midostaurin, - Indolent Systemic Mastocytosis | Phase 2 | Unknown | University Medical Center Groningen | 20 | 2013-08-01 | 2015-01-19 |
| Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia Decitabine, Midostaurin - Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in Adults, AML (Adult) With 11q23 (MLL) Abnormalities | Phase 2 | Terminated | David Iberri | 13 | 2013-06-01 | 2018-09-27 |
| Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML midostaurin (PKC412) - Acute Myeloid Leukemia | Phase 2 | Completed | Technische Universität Dresden | 18 | 2013-03-13 | 2020-08-06 |
| Protocol in Acute Myeloid Leukemia With FLT3-ITD Midostaurin, Cytarabine, Daunorubicin - Acute Myeloid Leukemia | Phase 2 | Completed | University of Ulm | 451 | 2012-05-01 | 2020-06-04 |
| PKC412 and 5-Azacytidine 5-azacytidine, PKC412 - Leukemia | Phase 1 / Phase 2 | Completed | M.D. Anderson Cancer Center | 54 | 2011-03-01 | 2018-10-16 |
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Leukemia, Myeloid, Acute (18) · Myelodysplastic Syndromes (4) · Mastocytosis, Systemic (3) · Aggression (2) · Leukemia (2) · Leukemia, Mast-Cell (2) · Blast Crisis (1) · Congenital Abnormalities (1) · GATA2 Deficiency (1) · Leukemia, Biphenotypic, Acute (1) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (1) · Mastocytosis (1) · Neoplasm, Residual (1) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (1) · Recurrence (1)
Novartis Pharmaceuticals (7) · M.D. Anderson Cancer Center (2) · Technische Universität Dresden (2) · Brenda Cooper, MD (1) · David Iberri (1) · Guenther Koehne (1) · Jason Robert Gotlib (1) · Mayo Clinic (1) · National Cancer Institute (NCI) (1) · Niguarda Hospital (1) · PrECOG, LLC. (1) · Stanford University (1) · Stichting Hemato-Oncologie voor Volwassenen Nederland (1) · University Hospital, Bordeaux (1) · University Medical Center Groningen (1)
United States (14) · Germany (7) · Netherlands (4) · France (3) · Italy (3) · Austria (2) · Belgium (2) · Canada (2) · Japan (2) · Poland (2) · Russia (2) · South Korea (2) · Turkey (Türkiye) (2) · Australia (1) · Czechia (1)
Aref Al-Kali (1) · Brenda Cooper, MD (1) · Brian Elliott, MD (1) · David Iberri, MD (1) · David J Iberri, MD (1) · Gerwin Huls, Prof (1) · Guenther Koehne, MD. PhD (1) · Hartmut Doehner, MD (1) · J.C. Kluin-Nelemans, MD, PhD (1) · Jason Robert Gotlib (1) · Jorge Cortes, MD (1) · Laura C Michaelis (1) · Maxim Norkin, MD, PhD (1)
PMID 27355533, PMID 28744009, PMID 29702001, PMID 29890238, PMID 30563875, PMID 32437738, PMID 33288862, PMID 34329576, PMID 35486475, PMID 39649724, PMID 40193193, PMID 40500616
2008 (2), 2017 (2), 2018 (2), 2019 (1), P30CA015083 (1), U10CA180888 (1)