A Phase 3 study of Zanubrutinib compared with Ibrutinib

• Research type

  Research Study

• Full title

  A Phase 3, Randomized Study of Zanubrutinib (BGB-3111) Compared with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

• IRAS ID

  253254

• Contact name

  Talha Munir

• Contact email

  tmunir@nhs.net

• Sponsor organisation

  BeiGene, Ltd.

• Eudract number

  2018-001366-42

• Duration of Study in the UK

  7 years, months, days

• Research summary

  This is a Phase 3, randomised study of zanubrutinib versus ibrutinib, sponsored by BeiGene, Ltd. Approximately 400 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will participate. \nCLL is the most common leukemia in the Western world. CLL is a treatable but essentially incurable disease. Inhibition of Bruton Tyrosine Kinase (BTK) has been shown to result in frequent and durable responses in patients with both previously untreated and relapsed CLL. \nZanubrutinib (also known as BGB-3111) is a potent, specific, and irreversible BTK inhibitor with a favorable pharmacologic and pharmacokinetic (PK) profile. The primary objective of this study is to compare the efficacy of zanubrutinib versus ibrutinib (also an inhibitor of BTK) as measured by overall response rate, determined by independent central review. \nOnce eligibility is confirmed, participants will be randomised in a 1:1 ratio to one of the following treatment arms: Arm A (Zanubrutinib 160 mg orally twice daily) or Arm B (Ibrutinib 420 mg orally once daily). \nEach participant is anticipated to be on the study approximately 50 months. There are three main phases to the study: screening, treatment and follow-up. Each study treatment cycle consists of 28 days. \nThe following procedures may be carried out: measurement of height, weight, and vital signs (blood pressure, pulse, and temperature), complete physical examination, blood sample collection (including a pregnancy test for women of child bearing potential and tests for Hepatitis B and C) an echocardiogram, multigated acquisition, or gated heart pool scan (screening only) and specialised CT scans (or MRI scans). Bone marrow samples will be collected. Participants will also be asked to complete questionnaires and a diary.\n\n
  Lay summary of study results:
  The lay summary will be published in below link in Feb2025.
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.beigene.com%252Fclinical-trials%252Fa-study-of-zanubrutinib-bgb-3111-versus-ibrutinib-in-participants-with-relapsed-refractory-chronic-lymphocytic-leukemia%252F%2FNBTI%2F5r_5AQ%2FAQ%2F45941b60-13a0-4af9-aaa0-44d4981ef644%2F3%2FpBN2zEchMk&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7C5a5fe89901e649bf8c9a08dd12cbe529%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638687389112684683%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=59vZwrhle3JRgM2UvN4iIMtbmozs7hthnASHLpTs52o%3D&reserved=0

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  18/YH/0477

• Date of REC Opinion

  14 Jan 2019

• REC opinion

  Further Information Favourable Opinion