for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion



This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Official 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


This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in approximately 600 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The primary efficacy endpoint is overall response rate determined by investigator assessment. Participants will be randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib will be open label.


Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL, SLL, relapsed, refractory, Lymphoma, Leukemia, Lymphoid Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Zanubrutinib, Ibrutinib


You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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


    17. Concurrent participation in another therapeutic clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


  • University of California Irvine Medical Center
    Orange California 92868 United States
  • David Geffen School of Medicine at UCLA
    Los Angeles California 90095 United States


in progress, not accepting new patients
Start Date
Completion Date
Phase 3 research study
Study Type
About 652 people participating
Last Updated