Ensayos clínicos

Inclusion Criteria:

• Documented diagnosis of B-cell CLL, according to International Workshop on Chronic Lymphocytic Leukemia 2008
• Presence of 17p deletion in CLL cells as demonstrated by fluorescence in-situ hybridization (FISH) testing
• No prior therapy for CLL other than corticosteroids for disease complications
• CLL that warrants treatment
• Presence of measurable lymphadenopathy
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria:

• Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
• Known presence of myelodysplastic syndrome
• History of a non-CLL malignancy except for the following:
  • the malignancy has been in remission without treatment for ≥ 5 years prior to enrollment, or
  • carcinoma in situ of the cervix, or
  • adequately treated basal or squamous cell skin cancer or other localized non-melanoma skin cancer, or
  • asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ≥ 1 year prior to enrollment, or
  • ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone, or
  • other adequately treated Stage 1 or 2 cancer currently in complete remission
• Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
• Ongoing liver injury
• History of noninfectious pneumonitis
• Ongoing inflammatory bowel disease
• History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
• Ongoing immunosuppressive therapy other than corticosteroids
• Received last dose of study drug on another therapeutic clinical trial within 30 days prior to enrollment
• Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality

Note: Other protocol defined Inclusion/Exclusion criteria may apply.