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A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B Cell) Treated With Asparaginase

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Trial Profile

A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention Versus No Systemic Anticoagulant Prophylaxis During Induction Chemotherapy in Children With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B Cell) Treated With Asparaginase

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2024

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At a glance

  • Drugs Apixaban (Primary)
  • Indications Deep vein thrombosis; Intracranial sinus thrombosis; Pulmonary embolism; Venous thromboembolism
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PREVAPIX-ALL
  • Sponsors Bristol-Myers Squibb

    • Most Recent Events

    • 12 Dec 2023 Results from sub-study assessing the efficacy and safety of prophylactic apixaban vs. SOC for VTE prevention during induction chemotherapy in obese pediatric patients with ALL/LL, presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 24 Mar 2023 Results deriving Data from a Phase 3 pediatric study NCT02369653; to assess apixaban pharmacokinetics (PK) and PK/pharmacodynamics (PD) in pediatric patients (pts) with ALL/LL to recommend doses in pts aged 28 days to 18 years, presented at the 124th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 01 Nov 2021 Status changed from recruiting to completed.
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