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DRUG CLASS:

DNA polymerase inhibitor

2d
Trial completion date
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RUNX1 (RUNX Family Transcription Factor 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • SRSF2 (Serine and arginine rich splicing factor 2) • BCOR (BCL6 Corepressor) • U2AF1 (U2 Small Nuclear RNA Auxiliary Factor 1) • STAG2 (Stromal Antigen 2) • ZRSR2 (Zinc Finger CCCH-Type, RNA Binding Motif And Serine/Arginine Rich 2)
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Chr del(11q)
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Vyxeos (cytarabine/daunorubicin liposomal formulation) • pomalidomide
3d
CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients (clinicaltrials.gov)
P2, N=60, Completed, Fred Hutchinson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2027 --> May 2026
Trial completion • Trial completion date
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Chr t(15;17)
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Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • cladribine • Starasid (cytarabine ocfosfate)
7d
Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine or CPX-351) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM) (clinicaltrials.gov)
P1, N=12, Recruiting, Nantes University Hospital | Not yet recruiting --> Recruiting | Trial completion date: Jan 2028 --> Aug 2028 | Trial primary completion date: Jan 2028 --> Aug 2028
Enrollment open • Trial completion date • Trial primary completion date • IO biomarker
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Darzalex (daratumumab) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • idarubicin hydrochloride
7d
ORAZ-351: Oral Azacitidine Maintenance Post-CPX 351 (clinicaltrials.gov)
P=N/A, N=100, Completed, Centre Hospitalier Universitaire de Nice | Recruiting --> Completed | Trial completion date: Jan 2025 --> Jun 2026 | Trial primary completion date: Jan 2025 --> Oct 2025
Trial completion • Trial completion date • Trial primary completion date
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Vyxeos (cytarabine/daunorubicin liposomal formulation) • Onureg (azacitidine oral)
17d
The Women TDF-FTC Benchmark Study (clinicaltrials.gov)
P2, N=72, Completed, University of Washington | Active, not recruiting --> Completed
Trial completion
20d
CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (clinicaltrials.gov)
P2, N=30, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jun 2026 --> Jun 2028
Trial completion date • Trial primary completion date
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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IDH1 R132
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Tibsovo (ivosidenib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
20d
CPX-351 as a Novel Approach for the Treatment of Older Patients With AML and MDS (clinicaltrials.gov)
P2, N=13, Active, not recruiting, Case Comprehensive Cancer Center | Trial completion date: Oct 2026 --> Jan 2027 | Trial primary completion date: Oct 2025 --> Jan 2026
Trial completion date • Trial primary completion date
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Vyxeos (cytarabine/daunorubicin liposomal formulation)
1m
Enrollment closed
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Vanflyta (quizartinib) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
1m
Enrollment open
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Lenvima (lenvatinib) • fostroxacitabine bralpamide (MIV-818)
1m
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)
2ms
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)