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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
Adults

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
IRB:PRO00089853
NCT:NCT03336333
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698