BeiGene: BGB-3111-304 Phase 3 BGB-3111 Untreated CLL/SLL - Clinical Trial
What is the Purpose of this Study?
We are doing this study to compare the effects, good or bad, of the investigational drug BGB-3111 versus a known standard treatment called bendamustine plus rituximab (B+R) on lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Who Can Participate in the Study?
- Have a confirmed diagnosis of CD20-positive CLL or SLL
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Have a life expectancy greater than or equal to 6 months
- Have adequate bone marrow and organ function
What is Involved?
If you choose to join this study, you will:
- Have tests, exams and procedures that are part of your standard care and for study purposes
- Complete questionnaires asking you about your general health, well-being, and overall quality-of-life
- Have your blood tested to find out whether you have CLL/SLL that has a mutation (a change) in one of the chromosomes called '17p deletion'
- Complete a drug diary to show when you have taken a study drug dose, or when you have missed a dose for any reason