A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria: * Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma. as per IW-CLL 2008 criteria. Patients must also require therapy for that diagnosis, based on meeting at least one of the following criteria: * evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin \<11.0 g/L) and/or thrombocytopenia (platelets \<100 x 10\^9/L) * massive (≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly * massive nodes (at least 10 cm longest diameter), progressive, or symptomatic lymphadenopathy * progressive lymphocytosis with an increase of more than 50% over a 2-month period or LDT of \<6 months. Lymphocyte doubling time may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In subjects with initial blood lymphocyte counts of \<30 x 10\^9/L, LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded * autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy * documented constitutional symptoms, defined as 1 or more of the following disease-related symptoms or signs: * unintentional weight loss \>10% within 6 months prior to screening * significant fati…