Therapy Detail
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| Therapy Name | Cytarabine + Idarubicin + Quizartinib |
| 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). |
| Quizartinib | Vanflyta | AC220 | FLT3 Inhibitor 69 | Vanflyta (quizartinib) is a small molecule that selectively inhibits FLT3, which may induce apoptosis and inhibit tumor growth (PMID: 19654408, PMID: 23497317). Vanflyta (quizartinib) is FDA-approved for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, in patients with newly diagnosed acute myeloid leukemia harboring FLT3 ITD mutations (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FLT3 exon 15 ins | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Quizartinib | Guideline | Actionable | Vanflyta (quizartinib) 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 exon 14 ins | acute myeloid leukemia | sensitive | Cytarabine + Idarubicin + Quizartinib | Guideline | Actionable | Vanflyta (quizartinib) 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... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04107727 | Phase II | Cytarabine Cytarabine + Idarubicin Cytarabine + Idarubicin + Quizartinib Quizartinib Cytarabine + Quizartinib | Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML) | Unknown status | ESP | 0 |
| NCT06578247 | Phase III | Cytarabine + Idarubicin Cytarabine + Idarubicin + Quizartinib Cytarabine + Daunorubicin Cytarabine + Daunorubicin + Quizartinib | Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML (QuANTUM-WILD) | Not yet recruiting | USA | SWE | ROU | POL | NOR | ITA | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUT | AUS | 8 |
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