For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria


  1. Confirmed diagnosis of CLL or SLL that meets the 2008 International Workshop on Chronic Lymphocytic Leukemia (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 Computerized Tomography (CT)/magnetic resonance imaging (MRI)
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  6. Life expectancy ≥ 6 months
  7. Adequate bone marrow function
  8. Adequate renal and hepatic function

EXCLUSION CRITERIA

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 (Burton's Kinase) 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.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Chronic Lymphocytic Leukemia,Small Lymphocytic Lymphoma

Age (in years)

18+

Phase

Phase 3

Participants needed

652

Est. Completion Date

Apr 30, 2024

Treatment type

Interventional


Sponsor

BeiGene

ClinicalTrials.gov identifier

NCT03734016

Study number

BGB-3111-305

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