Therapy Detail
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| Therapy Name | CPX-351 + Gemtuzumab ozogamicin |
| Synonyms | |
| Therapy Description |
Vyxeos (CPX-351) is a liposomal formulation of cytarabine and daunorubicin with anti-tumor activities (PMID: 25223583). Vyxeos (CPX-351) is FDA approved for use in patients with newly-diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| CPX-351 | Vyxeos | Liposome-encapsulated Daunorubicin-Cytarabine | Vyxeos (CPX-351) is a liposomal formulation of cytarabine and daunorubicin with anti-tumor activities (PMID: 25223583). Vyxeos (CPX-351) is FDA approved for use in patients with newly-diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes (FDA.gov). | |
| 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). |
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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 |
|---|---|---|---|---|---|---|
| NCT03878927 | Phase I | CPX-351 + Gemtuzumab ozogamicin | CPX-351+GO in Subjects 55 Years Old, or Older, With AML (CPX GO) | Terminated | USA | 0 |
| NCT03904251 | Phase I | CPX-351 + Gemtuzumab ozogamicin | CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia | Terminated | USA | 0 |
| NCT04915612 | Phase I | CPX-351 + Gemtuzumab ozogamicin | Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia | Recruiting | USA | 0 |
| NCT03672539 | Phase I | Gemtuzumab ozogamicin CPX-351 + Gemtuzumab ozogamicin | Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome | Recruiting | USA | 0 |
| NCT05558124 | Phase I | CPX-351 + Gemtuzumab ozogamicin | CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML | Recruiting | USA | 0 |
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