Last updated on August 2020

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Lymphocytic Leukemia | Lymphocytic Leukemia | Chronic
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Key Inclusion Criteria

  1. Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
  2. CLL/SLL requiring treatment per 2008 IWCLL criteria
  3. Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
  4. Measurable disease by CT/magnetic resonance imaging (MRI)
  5. ECOG performance status of 0, 1, or 2
  6. Life expectancy 6 months
  7. Adequate bone marrow function
  8. Adequate renal and hepatic function

Key Exclusion Criteria

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  2. Clinically significant cardiovascular disease.
  3. Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast
  4. History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
  5. History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
  6. Severe or debilitating pulmonary disease
  7. Active fungal, bacterial, and/or viral infection requiring systemic therapy
  8. Known central nervous system involvement by leukemia or lymphoma
  9. Known infection with HIV or active viral hepatitis B or C infection
  10. Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
  11. Major surgery within 4 weeks of the first dose of study drug
  12. Prior treatment with a BTK inhibitor
  13. Toxicity from prior anticancer therapy that has not recovered to Grade 1
  14. Pregnant or lactating women
  15. Vaccination with a live vaccine within 35 days prior to the first dose of study drug
  16. Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
  17. Concurrent participation in another therapeutic clinical trial

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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