A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Safety and Efficacy of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Trial Profile

A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Safety and Efficacy of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Oct 2018

At a glance

  • Drugs Zanubrutinib (Primary)
  • Indications Chronic lymphocytic leukaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors BeiGene
  • Most Recent Events

    • 24 Oct 2018 According to a BeiGene media release, Updated data with additional follow-up of the patients in the study will be submitted to the NMPA as an additional document of the NDA and are planned to be presented at an upcoming medical conference.
    • 24 Oct 2018 An independent review of response data (data cut-off of June 15, 2018) from the study presented in a BeiGene media release.
    • 24 Oct 2018 According to a BeiGene media release, the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) for zanubrutinib for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The NDA is supported by an extensive clinical, non-clinical and chemistry, manufacturing and control (CMC) data package, including the results from this trial.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top