Therapy Detail

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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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  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown acute myeloid leukemia not applicable CPX-351 FDA approved Actionable In a Phase III trial that supported FDA approval, Vyxeos (CPX-351) treatment resulted in improved overall survival (9.56 vs 5.95 months, HR=0.69, p=0.005), event-free survival (HR=0.74, p=0.021), and complete response rate (47.4% vs 33.3%, p=0.016) compared to Cytosar-U (cytarabine) and Cerubidine (daunorubicin) combination therapy in patients with acute myeloid leukemia (Journal of Clinical Oncology 34, no. 15_suppl (May 20 2016) 7000-7000; NCT01696084). detail... detail...

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  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03555955 Phase I CPX-351 A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 Recruiting
NCT03335267 Phase II CPX-351 Investigator Initiated Trial of CPX-351 for Untreated Acute Myeloid Leukemia Active, not recruiting
NCT03572764 Phase I CPX-351 CPX-351 (Vyxeos) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome Recruiting
NCT02286726 Phase II CPX-351 CPX-351 in Treating Patients With Newly Diagnosed, High-Risk Acute Myeloid Leukemia Completed
NCT03896269 Phase I CPX-351 CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Recruiting
NCT02019069 Phase II CPX-351 CPX-351 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Completed
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 Recruiting
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
NCT02533115 Expanded access CPX-351 EAP of CPX-351 (VYXEOS) for Patients 60-75 Years of Age With Secondary AML Approved for marketing
NCT04049539 Phase II CPX-351 Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction Not yet recruiting
NCT01943682 Phase I CPX-351 Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma Completed
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
NCT01804101 Phase I CPX-351 Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia Completed
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 Recruiting
NCT03526926 FDA approved CPX-351 A Post-Marketing Observational Study of VYXEOS Completed
NCT03957876 Phase II CPX-351 CPX-351 Therapy for MDS After Hypomethylating Agent Failure Recruiting
NCT03575325 Phase II CPX-351 Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia Recruiting
NCT03988205 FDA approved CPX-351 Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia Recruiting


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