This trial is looking at the effectiveness of zanubrutinib compared to ibrutinib in the treatment of patients with unresponsive or relapsed chronic lymphocytic leukemia (CLL). The main outcome to be measured will be overall response rate. The study will be carried out in the United States.
Chronic lymphocytic leukemia (CLL) is a cancer of the immune system. It is often linked with abnormal genes. Ibrutinib (Imbruvica) is commonly a first-line treatment for CLL. This may lose effectiveness over time. Zanubrutinib is a newer type of treatment that targets certain proteins on cancer cells.
This phase 3 trial compares the effectiveness of zanubrutinib and ibrutinib for the treatment of CLL. The main outcome to be measured will be the overall response rate.
Who are they looking for?
400 patients will be recruited for this clinical trial. Patients should have unresponsive CLL, measurable disease by CT/MRI imaging, and good bone marrow, kidney, and liver functions.
Patients should not have a history of bleeding disorder, stroke, heart disease, liver disease or major surgery within 4 weeks of starting the trial. Patients must not have other cancers in the past 3 years, an active infection needing treatment or a vaccination with a live vaccine within 35 days of the beginning of the study.
How will it work
There will be two groups for this trial. One group will receive zanubrutinib tablets twice a day. The second group will receive ibrutinib tablets once a day for comparison. Patients will be followed up for 80 months. The main outcomes measured will be a response to treatment, duration of response, survival and side effects.