Therapy Detail
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| Therapy Name | Decitabine + Quizartinib + Venetoclax |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Decitabine | Dacogen | 5-aza-2-deoxycytidine | DNMT inhibitor (Pan) 5 | Dacogen (decitabine) is cytidine analog that incorporates into DNA and forms covalent bonds with DNA methyltransferases (DNMTs), resulting in decreased DNMT activity and hypomethylation, and potentially leading to reduced tumor growth (PMID: 28159832, PMID: 25130173). Dacogen (decitabine) is FDA approved for use in patients with myelodysplastic syndromes (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). |
| Venetoclax | Venclexta | ABT-199|RG7601|GDC-0199|ABT119|Venclyxto | BCL2 inhibitor 27 | Venclexta (venetoclax) is a BH3-mimetic that binds to and inhibits BCL2, resulting in increased tumor cell apoptosis (PMID: 26589495, PMID: 25048785). Venclexta (venetoclax) is FDA approved for use in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in combination with chemotherapy in patients 75 years old or older with newly-diagnosed acute myeloid leukemia (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FLT3 exon 14 ins | acute myeloid leukemia | predicted - sensitive | Decitabine + Quizartinib + Venetoclax | Phase Ib/II | Actionable | In a Phase I/II trial, treatment with the combination of Vanflyta (quizartinib), Venclexta (venetoclax), and Dacogen (decitabine) resulted in a composite complete remission (CRc) rate of 68% (27/40), a median overall survival (OS) of 7.1 months, and a 1-year OS rate of 22% in relapsed/refractory acute myeloid leukemia patients with FLT3-ITD mutations, and in the frontline setting, the combination treatment resulted in a CRc of 100% (10/10) (Blood (2023) 142 (Supplement 1): 158; NCT03661307). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03661307 | Phase Ib/II | Decitabine + Quizartinib + Venetoclax | Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome | Recruiting | USA | 0 |
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