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A Phase 1/2 Study of Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy

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Trial Profile

A Phase 1/2 Study of Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 27 Jul 2023

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At a glance

  • Drugs Cytarabine (Primary) ; Venetoclax (Primary)
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors AbbVie

Most Recent Events

  • 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
  • 03 Aug 2022 According to ClinicalTrials.gov record, protocol has been amended to change in timeframe for primary end point from 24hours to 2,4,6,8 and 24 hrs and addition of Number of Participants With Dose-limiting Toxicities as primary end point.
  • 13 Jul 2022 Results published in the Clinical Drug Investigation

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