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    DRUG CLASS:

    DNA polymerase inhibitor

    Related drugs:
    8d
    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, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Vanflyta (quizartinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    19d
    FLEX-HCC: Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy (clinicaltrials.gov)
    P2, N=80, Recruiting, CHA University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Lenvima (lenvatinib) • fostroxacitabine bralpamide (MIV-818)
    19d
    Durable remission despite transplantation with active disease in therapy-related NUP98::TOP1-rearranged acute myeloid leukemia. (PubMed, Ann Hematol)
    Both patients achieved sustained long-term remission and are alive at 69 and 55 months after allo-HSCT, respectively, without significant transplant-related complications. While no conclusions on treatment efficacy can be drawn from this limited case series, these observations document durable remission despite the active disease at transplant in an ultra-high-risk setting and support further investigation of immune-based transplant strategies in NUP98-rearranged AML.
    Journal
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    NUP98 (Nucleoporin 98 And 96 Precursor 2)
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    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    28d
    Improving Access to PrEP (HIV Prevention Medication) for People in Underserved Areas of Rio de Janeiro (clinicaltrials.gov)
    P=N/A, N=400, Recruiting, Oswaldo Cruz Foundation
    New trial
    29d
    Determinants of survival in patients treated with CPX-351 for acute myeloid leukemia. (PubMed, Front Oncol)
    Leukocytosis at diagnosis, complex karyotype, and mutations of IDH1 and SRSF2 were correlated with lower survival in the univariable analysis. In the multivariable analysis, leukocytosis and complex karyotype retained their statistical significance.
    Journal
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    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • SRSF2 (Serine and arginine rich splicing factor 2)
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    IDH1 mutation • SRSF2 mutation
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    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    1m
    COSI: A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT (clinicaltrials.gov)
    P2/3, N=333, Active, not recruiting, University of Birmingham | Trial completion date: Mar 2025 --> May 2026 | Trial primary completion date: Mar 2025 --> May 2026
    Trial completion date • Trial primary completion date
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    Vyxeos (cytarabine/daunorubicin liposomal formulation) • fludarabine IV • thiotepa • busulfan
    1m
    Durvalumab and tremelimumab combination therapy achieved remarkable response in primary hepatic undifferentiated carcinoma with high PD-L1 expression. (PubMed, Clin J Gastroenterol)
    Shortly after treatment, the patient developed cranial nerve palsies (III, VII, VIII), suspected to represent either an immune-related adverse event or Ramsay Hunt syndrome; his symptoms improved with prednisolone and valaciclovir, allowing Dur/Tre to be resumed. To our knowledge, this is the first report of primary hepatic undifferentiated carcinoma with high PD-L1 expression demonstrating a sustained response to Dur/Tre. This case suggests that PD-L1 expression may serve as a potential biomarker for predicting ICI responsiveness in this rare and aggressive tumor.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1)
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    PD-L1 expression • PD-L1 overexpression
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    Imfinzi (durvalumab) • Imjudo (tremelimumab-actl) • valacyclovir
    2ms
    NCI-2019-03712: Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms (clinicaltrials.gov)
    P1/2, N=12, Terminated, Ohio State University Comprehensive Cancer Center | Completed --> Terminated; The study was originally planned to assess four escalating DLs of ruxolitinib (upto 40 mg twice daily), but was closed early due to slow enrollment and changing treatment landscape moving towards less intense approaches.
    Trial termination
    |
    Jakafi (ruxolitinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction (clinicaltrials.gov)
    P1/2, N=28, Recruiting, Ohio State University Comprehensive Cancer Center | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    ACX-362E [Ibezapolstat] for Oral Treatment of Recurrent Clostridioides Difficile Infection (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Acurx Pharmaceuticals Inc.
    New P2 trial
    2ms
    HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM (clinicaltrials.gov)
    P1/2, N=62, Recruiting, The Methodist Hospital Research Institute | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    ProstAtak (aglatimagene besadenovec) • valacyclovir
    2ms
    ALFA2101: CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics (clinicaltrials.gov)
    P2, N=248, Recruiting, Centre Hospitalier Universitaire de Nice | Trial completion date: Oct 2027 --> Feb 2030 | Trial primary completion date: Oct 2027 --> Aug 2028
    Trial completion date • Trial primary completion date
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation) • idarubicin hydrochloride