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A Single-arm, Pivotal Registration Phase II Study of the Efficacy and Safety of APG-2575 Monotherapy in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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Trial Profile

A Single-arm, Pivotal Registration Phase II Study of the Efficacy and Safety of APG-2575 Monotherapy in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 22 Nov 2024

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At a glance

  • Drugs Lisaftoclax (Primary)
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Ascentage Pharma
  • Most Recent Events

    • 17 Nov 2024 According to Ascentage Pharma media release, company announced that a New Drug Application for lisaftoclax, for the treatment of patients with relapsed or refractory (r/r) CLL/SLL has been accepted and recommended the Priority Review designation by the Center for Drug Evaluation) of China National Medical Products Administration. This NDA is based on results from this pivotal registrational Phase II study in China (APG2575CC201).
    • 22 Jan 2024 Planned End Date changed from 1 Jan 2024 to 1 Dec 2024.
    • 22 Jan 2024 Planned primary completion date changed from 1 Oct 2023 to 1 Sep 2024.

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