BGB-3111-304 (FL)

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 (CLL/SLL)

Study Treatments

• Arm 1: BGB-3111 oral twice a day (for patients without del17p)
• Arm 2: bendamustine + rituximab
• Arm 3: BGB-3111 oral twice a day (for patients with del17p)

Inclusion criteria

• Confirmed diagnosis of CD20-positive CLL or SLL
• Unsuitable for chemoimmunotherapy with FCR in the opinion of the investigator
• Binet Stage C disease, or Binet Stage B or A disease requiring treatment
• ECOG 0-2

Exclusion criteria

• Previous systemic treatment for CLL/SLL
• Known prolymphocytic leukemia or history of or 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, superficial bladder cancer, or carcinoma in situ of the cervix of breast
• Major surgery or significant injury ≤ 4 weeks prior to start of study treatment
• History of severe bleeding disorder

Participating sites

• UZ Brussel
• CHU UCL Namur - site Mont-Godinne