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A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2024

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At a glance

  • Drugs Acalabrutinib (Primary) ; Bendamustine (Primary) ; Rituximab (Primary)
  • Indications Mantle-cell lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms ECHO
  • Sponsors Acerta Pharma
  • Most Recent Events

    • 07 Nov 2024 According to AstraZeneca media release, data of updated analysis from the pivotal ECHO Phase III trial will be presented at at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition 7 to 10 December 2024.
    • 03 Oct 2024 According to AstraZeneca media release, AstraZeneca supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2025.
    • 03 Oct 2024 Results published in the AstraZeneca Media Release.

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