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A Phase 1/2 Open Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies

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Trial Profile

A Phase 1/2 Open Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Acalabrutinib (Primary)
  • Indications B-cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors AstraZeneca

    • Most Recent Events

    • 25 Feb 2025 Planned End Date changed from 29 Dec 2023 to 24 Jun 2026.
    • 01 May 2024 Results assessing safety and efficacy of acalabrutinib in Chinese patients with relapsed/refractory mantle cell lymphoma presented in the Leukemia and Lymphoma
    • 04 Sep 2023 According to an AstraZeneca media release, based on ASCEND Phase III trial and I/II study (NCT03932331), the National Medical Products Administration (NMPA) has approved Calquence (acalabrutinib), for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.

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