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 13 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
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 Active, not recruiting USA 0
NCT05599360 Phase II CPX-351 + Gemtuzumab ozogamicin Vyxeos for Induction of Low- or Intermediate-risk. Recruiting ISR 0
NCT03904251 Phase I CPX-351 + Gemtuzumab ozogamicin CPX-351 and Gemtuzumab Ozogamicin in Treating Patients With Relapsed Acute Myeloid Leukemia Terminated 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
NCT03878927 Phase I CPX-351 + Gemtuzumab ozogamicin CPX-351+GO in Subjects 55 Years Old, or Older, With AML (CPX GO) Terminated USA 0


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