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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).

What is the Condition Being Studied?

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Who Can Participate in the Study?

Adults who:
- 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

Age Group

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

Study Details

Full Title
An International, Phase 3, Open-label, Randomized Study of BGB-3111 Compared with Bendamustine plus Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
Phase III
Contact the Duke Recruitment Innovation Center