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    DRUG CLASS:

    DNA polymerase inhibitor

    Related drugs:
    1m
    Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P1/2, N=52, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    Vanflyta (quizartinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    1m
    NCI-2019-08946: CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old (clinicaltrials.gov)
    P2, N=21, Active, not recruiting, Roswell Park Cancer Institute | Suspended --> Active, not recruiting | N=46 --> 21 | Trial primary completion date: Jan 2027 --> Jun 2025
    Enrollment closed • Enrollment change • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    1m
    MCC-21450: CPX-351 in Combination With Gemtuzumab Ozogamicin in Newly Diagnosed AML (clinicaltrials.gov)
    P1, N=18, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2025 --> Apr 2027 | Trial primary completion date: Nov 2025 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    CD33 (CD33 Molecule)
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    1m
    CPX-351 and the Frontier of Nanoparticle-Based Therapeutics in Acute Myeloid Leukemia. (PubMed, Int J Mol Sci)
    Despite these gains, the absolute survival benefit remains modest, prolonged cytopenias are universal, and outcomes in TP53-mutated or younger adverse-risk patients are still poor, raising legitimate questions about cost-effectiveness and generalizability. Nonetheless, CPX-351 stands as the first clinically validated example of ratiometric nanomedicine in oncology, proving that reformulating established drugs can yield meaningful progress where novel agents have often failed.
    Review • Journal
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    TP53 (Tumor protein P53)
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    TP53 mutation
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    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    AAML1831: A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (clinicaltrials.gov)
    P3, N=1186, Recruiting, Children's Oncology Group | Trial completion date: Sep 2027 --> Jun 2029 | Trial primary completion date: Sep 2027 --> Jun 2029
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Starasid (cytarabine ocfosfate) • dexrazoxane
    2ms
    VYSION: VYxeoS Liposomal Italian Observational Study iN the Real Practice (clinicaltrials.gov)
    P=N/A, N=113, Completed, Jazz Pharmaceuticals | Active, not recruiting --> Completed | Trial completion date: Feb 2026 --> Oct 2025 | Trial primary completion date: Feb 2026 --> Oct 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    NCI-2019-08946: CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old (clinicaltrials.gov)
    P2, N=46, Suspended, Roswell Park Cancer Institute | Recruiting --> Suspended
    Trial suspension
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    CPX-351 versus daunorubicin, cytarabine plus gemtuzumab ozogamicin in older adults with non-adverse risk AML: NCRI AML18. (PubMed, Blood)
    For patients entering the course-2 randomisation (n=107) survival was equivalent between standard versus intensified CPX doses (P=0.565).In this population of older patients without known adverse-risk cytogenetics, DAGO2 resulted in superior survival compared to CPX. CPX did not benefit those with MDS-related mutations over DAGO2.
    Journal
    |
    FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1)
    |
    FLT3 mutation
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    NCI-2018-01812: Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (clinicaltrials.gov)
    P2, N=50, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Nov 2025 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    3ms
    Acute myeloid leukemia therapy in the era of comprehensive genomic profiling (PubMed, Rinsho Ketsueki)
    Some therapies have already been developed for actionable mutations: quizartinib for FLT3-ITD mutations is available for newly diagnosed AML, and ivosidenib for IDH1 mutations is awaiting approval...Decisions on allogeneic transplantation and accessibility of investigational drugs are also expected. Detailed diagnosis and prognosis prediction based on the profile of genetic abnormalities should enable precision medicine.
    Review • Journal
    |
    FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    FLT3-ITD mutation • IDH1 mutation
    |
    Vanflyta (quizartinib) • Tibsovo (ivosidenib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    3ms
    Auto Stem Cell Transplant for Lymphoma Patients (clinicaltrials.gov)
    P2, N=150, Recruiting, Masonic Cancer Center, University of Minnesota | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Sep 2025 --> Sep 2026
    Trial completion date • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase) • CD4 (CD4 Molecule) • TCL1A (TCL1 Family AKT Coactivator A)
    |
    ALK positive
    |
    cytarabine • cyclophosphamide • etoposide IV • carmustine • melphalan • Depocyte (liposomal cytarabine) • Neupogen (filgrastim)