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Therapy Name | Cytarabine + Idarubicin + Midostaurin |
Synonyms | |
Therapy Description | |
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 | Idarubicin is an anthracycline, which inhibits DNA replication thereby preventing RNA and protein synthesis and, 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 66 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). |
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 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 |
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 | ITA | FRA | ESP | DEU | BEL | AUT | AUS | 12 |