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A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are ≥ 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy

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A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are ≥ 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 20 Sep 2024

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At a glance

  • Drugs Venetoclax (Primary) ; Azacitidine; Azacitidine; Decitabine; Posaconazole
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors AbbVie

    • Most Recent Events

    • 12 Dec 2023 Results of pooled analysis, evaluating the outcomes of Ven+Aza across elderly age cohorts in patients with ND AML from NCT02203773 and Ven+Aza versus Pbo+Aza in patients with ND AML who were IC-ineligible from NCT02993523, presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 15 Jun 2023 Results (n=401 from studies NCT02993523, NCT02203773, NCT03069352, andNCT02287233) assessing dysregulation of the integrated stress response (ISR) pathway in pts with TP53mut, specificallythrough the actions of DAP3 binding cell death enhancer 1 (DELE1) and its activating protease OMA1 presented at the 28th Congress of the European Haematology Association
    • 15 Jun 2023 Results of post hoc analysis (n=141 from studies NCT02203773 and NCT02993523) assessing findings by AML differentiation status using French-American British (FAB) subtyping (M4, M5) andgene expression profiling presented at the 28th Congress of the European Haematology Association

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