Therapy Detail
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| Therapy Name | Azacitidine + Cytarabine + Fludarabine + Gemtuzumab ozogamicin + Venetoclax |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Azacitidine | Vidaza | azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg | DNMT inhibitor (Pan) 5 | Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov). |
| Cytarabine | Cytosar-U | Ara-C | Cytosar-U (cytarabine) is a cytidine analog that, when incorporated into DNA, inhibits DNA synthesis and repair (PMID: 32524309). | |
| Fludarabine | Fludara | FAMP|Fludarabine phosphate | Flurdara (fludarabine) is converted to 2-fluoro-ara-ATP intracellularly, which potentially inhibits DNA polymerase alpha, ribonucleotide reductase and DNA primase, leading to decreased DNA synthesis and reduced tumor growth (NCI Drug Dictionary) | |
| Gemtuzumab ozogamicin | Mylotarg | gemtuzumab|CDP-771|CMA-676|WAY-CMA-676 | CD33 Antibody 12 | Mylotarg (gemtuzumab ozogamicin) is an antibody-drug conjugate comprising an anti-CD33 antibody linked to the cytotoxic agent calicheamicin, which results in DNA damage in CD33-expressing tumor cells (PMID: 28607471). Mylotarg (gemtuzumab ozogamicin) is FDA approved for newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adult and pediatric patients 1 month and older, and in relapsed or refractory CD33-positive AML in adult and pediatric patients 2 years and older (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 |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05183035 | Phase III | Azacitidine + Cytarabine + Fludarabine + Gemtuzumab ozogamicin + Venetoclax Azacitidine + Cytarabine + Fludarabine + Gemtuzumab ozogamicin | Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) | Recruiting | USA | NZL | NLD | ITA | FRA | ESP | CAN | BEL | AUT | AUS | 7 |
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