25 completed, 6 terminated, 4 active not recruiting, 4 withdrawn. 26 Phase 2, 20 Phase 1, 7 Phase 3.
Follow midostaurin: new trials by email Literature Review of midostaurin trials Research Report on midostaurin
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 |
| Revumenib in Combination With 7+3 + Midostaurin in AML Revumenib, Midostaurin, Cytarabine - Acute Myeloid Leukemia, AML, Adult | Phase 1 | Recruiting | Richard Stone, MD | 22 | 2024-12-06 | 2026-03-25 |
| 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With FLT3 Mutated Acute Myeloid Leukemia CPX-351, Midostaurin, Busulfan - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Withdrawn | Guenther Koehne | 2022-07-05 | 2024-10-01 | |
| Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) Midostaurin - Acute Myeloid Leukemia (AML) | Completed | Novartis Pharmaceuticals | 81 | 2020-09-24 | 2022-11-08 | |
| 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 |
| HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt. HDM201, Midostaurin - AML, Adult | Phase 1 | Terminated | Insel Gruppe AG, University Hospital Bern | 2 | 2020-07-13 | 2022-10-06 |
| AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance Cytarabine, Daunorubicin, Midostaurin - Acute Myeloid Leukemia With FLT3/ITD Mutation | Phase 3 | Unknown | Gruppo Italiano Malattie EMatologiche dell'Adulto | 172 | 2020-04-24 | 2022-03-02 |
| 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 |
| 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 Gilteritinib, Midostaurin - Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2 | Phase 3 | Active not recruiting | Stichting Hemato-Oncologie voor Volwassenen Nederland | 777 | 2019-12-20 | 2024-12-17 |
| 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 |
| A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia CPX-351, Venetoclax, Midostaurin - Acute Myeloid Leukemia | Phase 1 | Completed | Jazz Pharmaceuticals | 57 | 2019-12-02 | 2023-10-16 |
| 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 |
| 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 Allogeneic Hematopoietic Stem Cell Transplantation, Cytarabine, Daunorubicin Hydrochloride - Acute Myeloid Leukemia | Phase 1 | Completed | Uma Borate | 21 | 2019-03-13 | 2026-05-15 |
| 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 | |
| Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML Crenolanib, Midostaurin, Cytarabine - Newly Diagnosed FLT3 Mutated AML | Phase 3 | Completed | Arog Pharmaceuticals, Inc. | 214 | 2018-08-15 | 2026-04-09 |
| 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) Midostaurin, Placebo, Chemotherapy - Acute Myeloid Leukemia (AML) | Phase 3 | Completed | Novartis Pharmaceuticals | 511 | 2018-07-20 | 2023-08-21 |
| 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 |
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Leukemia, Myeloid, Acute (36) · Myelodysplastic Syndromes (7) · Leukemia (5) · Congenital Abnormalities (4) · Mastocytosis, Systemic (4) · Leukemia, Mast-Cell (3) · Aggression (2) · Neoplasm, Residual (2) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (2) · Blast Crisis (1) · GATA2 Deficiency (1) · Leukemia, Basophilic, Acute (1) · Leukemia, Biphenotypic, Acute (1) · Leukemia, Eosinophilic, Acute (1) · Leukemia, Erythroblastic, Acute (1)
Novartis Pharmaceuticals (16) · M.D. Anderson Cancer Center (2) · Richard Stone, MD (2) · Stichting Hemato-Oncologie voor Volwassenen Nederland (2) · Technische Universität Dresden (2) · Alison Walker (1) · Alliance for Clinical Trials in Oncology (1) · Arog Pharmaceuticals, Inc. (1) · Brenda Cooper, MD (1) · David Iberri (1) · Gruppo Italiano Malattie EMatologiche dell'Adulto (1) · Guenther Koehne (1) · Insel Gruppe AG, University Hospital Bern (1) · Jason Robert Gotlib (1) · Jazz Pharmaceuticals (1)
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Richard Stone, MD (2) · Alison Walker, MD (1) · Aref Al-Kali (1) · Brenda Cooper, MD (1) · Brian Elliott, MD (1) · Camille Abboud, M.D. (1) · Casey Williams, PharmD (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)
PMID 22627678, PMID 27355533, PMID 24488798, PMID 26784138, PMID 28644114, PMID 28744009, PMID 29702001, PMID 29890238, PMID 30382485, PMID 30563875, PMID 31171508, PMID 31375516, PMID 32437738, PMID 32812818, PMID 33049054, PMID 33288862, PMID 34329576, PMID 35486475, PMID 36184192, PMID 37581981, PMID 39649724, PMID 40193193, PMID 40500616, PMID 40932876, PMID 41432755, PMID 41488889
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