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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: 02 Apr 2025

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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

  • 31 Mar 2025 According to an AstraZeneca media release, Martin Dreyling is an investigator in the trial.
  • 31 Mar 2025 According to an AstraZeneca media release, based on data rom this study, calquence in combination with bendamustine and rituximab has been recommended for approval by CHMP of the European Medicines Agency (EMA) in the EU for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous hematopoietic stem cell transplantation.The recommendation follows the recent CHMP positive opinion.
  • 17 Jan 2025 According to an AstraZeneca media release, regulatory applications are also under review in the EU, Japan, and other countries based on the ECHO results.

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