Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Patients in this trial will be randomised 1:1 to receive an oral 160mg dose of Zanubrutinib twice daily or an oral 420mg dose of Ibrutinib once daily. The primary endpoint for the trial will be overall response rate as determined by independent central review.
Conditions
This trial is treating people with chronic lymphocytic leukaemia or small lymphocytic lymphoma
Eligibility
Inclusion
- Confirmed diagnosis of CLL or SLL that meets the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
- CLL/SLL requiring treatment per 2008 IWCLL criteria
- Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
- Measurable disease by Computerized Tomography (CT)/magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy ≥ 6 months
- Adequate bone marrow function
- Adequate renal and hepatic function
Exclusion
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Clinically significant cardiovascular disease.
- 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
- History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
- Severe or debilitating pulmonary disease
- Active fungal, bacterial, and/or viral infection requiring systemic therapy
- Known central nervous system involvement by leukemia or lymphoma
- Known infection with HIV or active viral hepatitis B or C infection
- Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
- Major surgery within 4 weeks of the first dose of study drug
- Prior treatment with a (Burton's Kinase) BTK inhibitor
- Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
- Pregnant or lactating women
- Vaccination with a live vaccine within 35 days prior to the first dose of study drug
- Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
- Concurrent participation in another therapeutic clinical trial
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
BeiGene Australia Pty Ltd
Scientific 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
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