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    DRUG CLASS:

    DNA polymerase inhibitor

    Related drugs:
    1d
    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
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    Vyxeos (cytarabine/daunorubicin liposomal formulation) • idarubicin hydrochloride
    1d
    Clinical strategies for leukemia management: Recommendations from the Bridging the Gaps in Hematology Oncology Consensus Conference 2025. (PubMed, Leuk Res)
    For ALL, recommendations highlighted avoiding transplant in most Philadelphia chromosome-positive patients achieving minimal residual disease (MRD)-negativity by noting the high relapse risk with certain IKZF1, CDKN2A/B, and PAX5 aberrations, and administering blinatumomab regardless of MRD status in Philadelphia chromosome-positive and -negative ALL...Future directions include refining treatment sequencing, improving outcomes for high-risk subtypes, evaluating the role of HSCT in the era of novel therapies, and standardizing MRD assessment. This consensus report provides valuable expert insights to inform clinical practice and guide future research in leukemia.
    Journal
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    TP53 (Tumor protein P53) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • IKZF1 (IKAROS Family Zinc Finger 1) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • PAX5 (Paired Box 5)
    |
    TP53 mutation
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    Blincyto (blinatumomab) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    4d
    FLEX-HCC: Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, CHA University
    New P2 trial
    |
    Lenvima (lenvatinib) • fostroxacitabine bralpamide (MIV-818)
    6d
    Phase IB/II of CPX-351 for Relapse Prevention in AML (clinicaltrials.gov)
    P1/2, N=24, Recruiting, Georgetown University | 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)
    18d
    Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors (clinicaltrials.gov)
    P1, N=11, Recruiting, University of Michigan Rogel Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    26d
    Virus-Based Gene Therapy (AdV-HSV1-TK and AdV-Flt3L) in Combination With Valacyclovir for the Treatment of Pediatric and Young Adult Patients With Resectable, Recurrent Primary Malignant Brain Tumors (clinicaltrials.gov)
    P1, N=11, Not yet recruiting, University of Michigan Rogel Cancer Center | Trial completion date: Jan 2031 --> Jun 2031 | Initiation date: Jan 2026 --> Jun 2026 | Trial primary completion date: Jan 2031 --> Jun 2031
    Trial completion date • Trial initiation date • Trial primary completion date
    1m
    Tazemetostat and Palbociclib With CPX-351for R/R AML (clinicaltrials.gov)
    P1, N=24, Recruiting, Thomas Jefferson University | Suspended --> Recruiting | Trial completion date: Jan 2026 --> Jan 2029 | Trial primary completion date: Jan 2026 --> Jan 2028
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Ibrance (palbociclib) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • Tazverik (tazemetostat)
    1m
    Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1 (clinicaltrials.gov)
    P2, N=54, Completed, University of North Carolina, Chapel Hill | Active, not recruiting --> Completed
    Trial completion
    1m
    IPrEP Men's Study: Expanding the Reach of Prevention for Men in Kisumu, Kenya (clinicaltrials.gov)
    P1, N=120, Completed, Columbia University | Not yet recruiting --> Completed | Phase classification: PN/A --> P1
    Trial completion • Phase classification
    2ms
    Short-cycle three-day-per-week efavirenz/emtricitabine/tenofovir disoproxil fumarate therapy: a seven-year extension study. (PubMed, J Antimicrob Chemother)
    A three-day-per-week regimen of efavirenz, emtricitabine, and tenofovir disoproxil fumarate maintained durable long-term viral suppression, while mitigating but not fully preventing toxicities associated with EFV/TDF/FTC. These findings support reduced-exposure antiretroviral therapy and warrant evaluation of similar strategies with modern integrase inhibitor-based regimens.
    Clinical • Journal
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    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    2ms
    Adverse karyotype amplifies risk in secondary acute myeloid leukemia (AML) and AML with myelodysplasia-related changes. (PubMed, Hematology)
    sAML/AML-MRC with an adverse karyotype had a dismal outcome. These findings provide a benchmark for risk stratification in the pre- CPX-351 era.
    Retrospective data • Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)
    2ms
    CPX-351 Selectively Benefits Patients with AML and Myelodysplasia-Related Mutations in the Pivotal Randomized Trial. (PubMed, Blood Adv)
    The OS benefit of CPX-351 observed in the trial was driven by AML-MR with no benefit of CPX-351 in TP53-AML, where the primary prognostic factor was allelic state. Clinical Trial Information: NCT01696084.
    Journal
    |
    TP53 (Tumor protein P53) • DDX41 (DEAD-Box Helicase 41)
    |
    TP53 mutation
    |
    Vyxeos (cytarabine/daunorubicin liposomal formulation)