- 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 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
- Known histological transformation from CLL to an aggressive lymphoma (ie, Richter
- 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
- 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
- Ongoing liver injury
- History of noninfectious pneumonitis.
- Ongoing inflammatory bowel disease.
- History of prior allogeneic bone marrow progenitor cell or solid organ
- 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
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both