- Subject must be refractory or have relapsed after receiving at least one prior line of therapy (subjects that have progressed after 1 cycle of treatment or have completed at least 2 cycles of treatment for a given line of therapy) or previously untreated CLL (previously untreated CLL subjects must have received no prior chemotherapy or immunotherapy. Subjects with a history of emergency, loco-regional radiotherapy (e.g., for relief of compressive signs or symptoms) are eligible. In addition, subjects must meet the CLL diagnostic criteria above and must have > 5 × 109/L B Lymphocytes in the peripheral blood.);