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 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).

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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 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

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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 | ITA | FRA | ESP | DEU | BEL | AUT | AUS 12


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