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Therapy Name CPX-351
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).

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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
NCT04195945 Phase II CPX-351 Cladribine + Cytarabine + Filgrastim + Mitoxantrone CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients Recruiting USA 0
NCT05554406 Phase II Cytarabine + Daunorubicin Azacitidine + Venetoclax CPX-351 Cytarabine + Daunorubicin + Venetoclax CPX-351 + Venetoclax Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) Recruiting USA 1
NCT05564390 Phase II Cytarabine + Venetoclax Cytarabine + Daunorubicin + Venetoclax CPX-351 + Venetoclax Cytarabine + Daunorubicin Cytarabine Azacitidine + Gilteritinib + Venetoclax Azacitidine + Venetoclax CPX-351 MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) Recruiting USA | CAN 1
NCT01943682 Phase I CPX-351 Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma Completed USA 0
NCT03957876 Phase II CPX-351 CPX-351 Therapy for MDS After Hypomethylating Agent Failure Terminated USA 0
NCT03988205 FDA approved CPX-351 Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia Terminated USA 0
NCT03572764 Phase I CPX-351 CPX-351 (Vyxeos) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome Active, not recruiting USA 0
NCT02019069 Phase II CPX-351 CPX-351 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Completed USA 0
NCT03226418 Phase II Cytarabine Decitabine + Venetoclax Azacitidine + Venetoclax CPX-351 Cytarabine + Idarubicin Azacitidine + Glasdegib Decitabine + Glasdegib Cytarabine, Idarubicin, Liposome-encapsulated Daunorubicin-Cytarabine or Decitabine in Treating Older Patients With Acute Myeloid Leukemia Active, not recruiting USA 0
NCT03335267 Phase II CPX-351 Investigator Initiated Trial of CPX-351 for Untreated Acute Myeloid Leukemia Completed USA 0
NCT03896269 Phase I CPX-351 CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Recruiting USA 0
NCT01804101 Phase I CPX-351 Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia Completed USA 0
NCT04049539 Phase II CPX-351 Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction Recruiting USA 0
NCT03393611 Phase I anti-thymocyte globulin + Fludarabine + Melphalan CPX-351 CPX-351 Salvage Therapy Followed by Haplo-Cord Transplant for Relapsed/Refractory Leukemia or Myelodysplastic Syndrome Completed USA 0
NCT02269579 Phase II CPX-351 Pharmacokinetic and Pharmacodynamic Assessment of Treatment With CPX-351 (Cytarabine: Daunorubicin) Liposome for Injection in Acute Leukemias and MDS Patients With Moderate Hepatic Impairment Withdrawn USA 0
NCT03575325 Phase II CPX-351 Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia Completed USA 0
NCT03526926 FDA approved CPX-351 A Post-Marketing Observational Study of VYXEOS Completed USA 0
NCT03555955 Phase I CPX-351 A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 Completed USA | CAN 0
NCT02286726 Phase II CPX-351 CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia Completed USA 0
NCT02533115 Expanded access CPX-351 EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AML Approved for marketing USA 0


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