Therapy Detail
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| Therapy Name | Cytarabine + Idarubicin + Midostaurin |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cytarabine | Cytosar-U | Ara-C | Cytosar-U (cytarabine) is a cytidine analog that, when incorporated into DNA, inhibits DNA synthesis and repair (PMID: 32524309). | |
| Idarubicin | Idamycin | Idarubicin Hcl | Chemotherapy - Anthracycline 13 | Idamycin (idarubicin) is an anthracycline that inhibits DNA replication thereby preventing RNA and protein synthesis, which may lead to tumor growth inhibition (PMID: 2192943). Idamycin (idarubicin) in combination with other approved drugs is FDA-approved for acute myelogenous leukemia (FDA.gov). |
| Midostaurin | Rydapt | PKC412|CGP 41251 | CSF1R Inhibitor 28 FLT3 Inhibitor 69 KIT Inhibitor 57 PKC alpha Inhibitor 6 PKC beta Inhibitor 6 PKC Inhibitor (Pan) 11 VEGFR2 Inhibitor 37 | Rydapt (midostaurin) is a multi-kinase inhibitor with activity against FLT3, KIT, PDGFRB, KDR (VEGFR2) and PKC, with higher selectivity for conventional PKC isoforms, which induces cell cycle arrest and apoptosis (PMID: 12124173, PMID: 23127174, PMID: 15914319). Rydapt (midostaurin) is FDA approved for FLT3-mutant AML in combination with chemotherapy, and is approved for use in aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, or mast cell leukemia as a single therapy (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FLT3 Y842D | acute myeloid leukemia | predicted - sensitive | Cytarabine + Idarubicin + Midostaurin | Case Reports/Case Series | Actionable | In a clinical case study, Rydapt (midostaurin), Cytosar-U (cytarabine), and Idamycin (idarubicin) combination therapy resulted in complete morphological remission, allowing for subsequent allogeneic stem cell transplantation, in a patient with acute myeloid leukemia harboring FLT3 Y842D (PMID: 35549749). | 35549749 |
| FLT3 exon19 | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Midostaurin | Guideline | Actionable | Rydapt (midostaurin) in combination with Idamycin (idarubicin) and Cytosar-U (cytarabine) is included in guidelines for patients with acute myeloid leukemia harboring a mutation in the FLT3 tyrosine kinase domain (exons 14-23) (NCCN.org). | detail... |
| FLT3 exon 14 ins | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Midostaurin | Guideline | Actionable | Rydapt (midostaurin) in combination with Idamycin (idarubicin) and Cytosar-U (cytarabine) is included in guidelines (category 1) for patients with acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (NCCN.org). | detail... |
| FLT3 exon14 | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Midostaurin | Guideline | Actionable | Rydapt (midostaurin) in combination with Idamycin (idarubicin) and Cytosar-U (cytarabine) is included in guidelines for patients with acute myeloid leukemia harboring a mutation in the FLT3 tyrosine kinase domain (exons 14-23) (NCCN.org). | detail... |
| FLT3 exon15 | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Midostaurin | Guideline | Actionable | Rydapt (midostaurin) in combination with Idamycin (idarubicin) and Cytosar-U (cytarabine) is included in guidelines for patients with acute myeloid leukemia harboring a mutation in the FLT3 tyrosine kinase domain (exons 14-23) (NCCN.org). | detail... |
| FLT3 exon20 | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Midostaurin | Guideline | Actionable | Rydapt (midostaurin) in combination with Idamycin (idarubicin) and Cytosar-U (cytarabine) is included in guidelines for patients with acute myeloid leukemia harboring a mutation in the FLT3 tyrosine kinase domain (exons 14-23) (NCCN.org). | detail... |
| FLT3 exon 15 ins | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Midostaurin | Guideline | Actionable | Rydapt (midostaurin) in combination with Idamycin (idarubicin) and Cytosar-U (cytarabine) is included in guidelines for patients with acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (NCCN.org). | detail... |
| FLT3 exon16 | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Midostaurin | Guideline | Actionable | Rydapt (midostaurin) in combination with Idamycin (idarubicin) and Cytosar-U (cytarabine) is included in guidelines for patients with acute myeloid leukemia harboring a mutation in the FLT3 tyrosine kinase domain (exons 14-23) (NCCN.org). | detail... |
| FLT3 exon17 | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Midostaurin | Guideline | Actionable | Rydapt (midostaurin) in combination with Idamycin (idarubicin) and Cytosar-U (cytarabine) is included in guidelines for patients with acute myeloid leukemia harboring a mutation in the FLT3 tyrosine kinase domain (exons 14-23) (NCCN.org). | detail... |
| FLT3 exon18 | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Midostaurin | Guideline | Actionable | Rydapt (midostaurin) in combination with Idamycin (idarubicin) and Cytosar-U (cytarabine) is included in guidelines for patients with acute myeloid leukemia harboring a mutation in the FLT3 tyrosine kinase domain (exons 14-23) (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03512197 | Phase III | Daunorubicin + Midostaurin Cytarabine + Idarubicin + Midostaurin Cytarabine + Idarubicin Daunorubicin | 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) | Completed | USA | TUR | POL | NOR | ITA | ISR | FRA | ESP | DEU | CZE | CHE | BRA | BGR | BEL | AUT | AUS | ARG | 3 |
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