Therapy Detail
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| Therapy Name | Cytarabine + Gilteritinib + Idarubicin |
| 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). | |
| Gilteritinib | Xospata | ASP2215 | AXL Inhibitor 30 FLT3 Inhibitor 69 | Xospata (gilteritinib) is a small molecule inhibitor of FLT3 and AXL that has activity against FLT3-ITD, FLT3 F691L, and FLT3 D835 mutations, potentially resulting in decreased tumor growth (J Clin Oncol 32:5s, 2014 (suppl; abstr 7070), PMID: 25891481). Xospata (gilteritinib) is FDA approved for use in patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation (ITD, D835X, and I836X) (FDA.gov). |
| 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). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FLT3 D835X | acute myeloid leukemia | predicted - sensitive | Cytarabine + Gilteritinib + Idarubicin | Phase I | Actionable | In a Phase Ib trial, the addition of Xospata (gilteritinib) to induction and consolidation chemotherapy (cytarabine plus idarubicin or daunorubicin), followed by Xospata (gilteritinib) maintenance was well tolerated and resulted in a composite complete response rate of 89% (32/36) and a median overall survival of 46.1 mo in patients with acute myeloid leukemia harboring FLT3 mutations, including FLT3-ITD and/or D835 mutations (n=25 with FLT3-ITD, 5 with D835, and 10 with both) (PMID: 37379495; NCT02236013). | 37379495 |
| FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | Cytarabine + Gilteritinib + Idarubicin | Phase I | Actionable | In a Phase Ib trial, the addition of Xospata (gilteritinib) to induction and consolidation chemotherapy (cytarabine plus idarubicin or daunorubicin), followed by Xospata (gilteritinib) maintenance was well tolerated and resulted in a composite complete response rate of 89% (32/36) and a median overall survival of 46.1 mo in patients with acute myeloid leukemia harboring FLT3 mutations, including FLT3-ITD and/or D835 mutations (n=25 with FLT3-ITD, 5 with D835, and 10 with both) (PMID: 37379495; NCT02236013). | 37379495 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|
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