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DRUG CLASS:

DNA polymerase inhibitor

1d
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
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TP53 (Tumor protein P53) • DDX41 (DEAD-Box Helicase 41)
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TP53 mutation
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Vyxeos (cytarabine/daunorubicin liposomal formulation)
3d
A Randomized Controlled Clinical Study on Transfer Factor Oral Solution in the Treatment of Herpes Zoster (ChiCTR2600117507)
P4, N=90, Recruiting, Dermatology Hospital, Southern Medical University; Dermatology Hospital, Southern Medical University
New P4 trial
11d
New P2 trial
2ms
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
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Vanflyta (quizartinib) • 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=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
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Vyxeos (cytarabine/daunorubicin liposomal formulation)
2ms
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
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CD33 (CD33 Molecule)
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Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
2ms
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
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FLT3 (Fms-related tyrosine kinase 3)
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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
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Vyxeos (cytarabine/daunorubicin liposomal formulation)
3ms
Trial suspension
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Vyxeos (cytarabine/daunorubicin liposomal formulation)