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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

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 Aug 2021

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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

    • 23 Aug 2021 Status changed from active, no longer recruiting to completed.
    • 16 Oct 2020 According to an AbbVie media release, The FDA reviewed the clinical data under the FDA's Real-Time Oncology Review (RTOR) pilot program and Project Orbis initiative.
    • 16 Oct 2020 According to an AbbVie media release, the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. The approval is supported by the data from VIALE-A, VIALE-C, M14-358 and M14-387 studies.
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