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DRUG CLASS:

DNA polymerase inhibitor

3d
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
14d
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)
21d
Trial suspension
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Vyxeos (cytarabine/daunorubicin liposomal formulation)
21d
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
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FLT3 (Fms-related tyrosine kinase 3) • NPM1 (Nucleophosmin 1)
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FLT3 mutation
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Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
24d
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
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CD33 (CD33 Molecule)
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CD33 positive
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Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
30d
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
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FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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FLT3-ITD mutation • IDH1 mutation
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Vanflyta (quizartinib) • Tibsovo (ivosidenib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
1m
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
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ALK (Anaplastic lymphoma kinase) • CD4 (CD4 Molecule) • TCL1A (TCL1 Family AKT Coactivator A)
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ALK positive
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cytarabine • cyclophosphamide • etoposide IV • carmustine • melphalan • Depocyte (liposomal cytarabine) • Neupogen (filgrastim)
1m
Effects of Antiviral Therapies on Epstein-Barr Virus Replication (clinicaltrials.gov)
P2, N=50, Enrolling by invitation, Massachusetts General Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
Trial completion date • Trial primary completion date
1m
A Phase 2 study of CPX-351 in combination with venetoclax in patients with newly diagnosed high-risk acute myeloid leukemia. (PubMed, Hemasphere)
The most common adverse events were related to myelosuppression. CPX + VEN resulted in high remission rates and enabled progression to allogenic SCT for the majority of a highly adverse group of ND AML patients.
P2 data • Journal
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TP53 (Tumor protein P53)
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TP53 mutation
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Venclexta (venetoclax) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
2ms
Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms (clinicaltrials.gov)
P2, N=25, Active, not recruiting, St. Jude Children's Research Hospital | Recruiting --> Active, not recruiting
Enrollment closed
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TP53 (Tumor protein P53) • NF1 (Neurofibromin 1) • RUNX1 (RUNX Family Transcription Factor 1) • ETV6 (ETS Variant Transcription Factor 6) • CEBPA (CCAAT Enhancer Binding Protein Alpha) • CD4 (CD4 Molecule) • MECOM (MDS1 And EVI1 Complex Locus) • GATA2 (GATA Binding Protein 2) • ANKRD26 (Ankyrin Repeat Domain Containing 26)
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Vyxeos (cytarabine/daunorubicin liposomal formulation)
2ms
Neonatal Phase 1 Valacyclovir Study (clinicaltrials.gov)
P1, N=17, Completed, National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting --> Completed
Trial completion
2ms
HPTN 083: Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (clinicaltrials.gov)
P2/3, N=4570, Completed, National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting --> Completed
Trial completion