A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination with Chlorambucil, ACP 196 in Combination with Obinutuzumab, and ACP-196 Monotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia

You may be able to join if

• "• Men and women ≥ 65 years of age, or > 18 and < 65 years of age provided that they meet at least one of the following criteria: o Creatinine clearance 30 to 69 mL/min using the Cockcroft-Gault equation. o A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric (CIRS-G). • ECOG performance status of 0, 1, or 2. • Diagnosis of CD20+ CLL that meets published diagnostic criteria (Hallek 2008) • Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment: o Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL). o Massive (ie, ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly. o Massive nodes (ie, ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy. o Progressive lymphocytosis with an increase of > 50% over a 2-month period or a lymphocyte doubling time (LDT) of < 6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts (ALC) 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 (30,000/μL), 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. o Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy. o Constitutional symptoms documented in the subject's chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs: - Unintentional weight loss ≥ 10% within the previous 6 months before Screening. - Significant fatigue (ie, ECOG performance status 2; inability to work or perform usual activities). - Fevers higher than 100.5°F or 38.0°C for 2 or more weeks before Screening without evidence of infection. - Night sweats for > 1 month before Screening without evidence of infection. • Meet the following laboratory parameters: o Absolute neutrophil count ≥ 750 cells/μL (0.75 x 10^9/L) or ≥ 500 cells/μL (0.50 x 10^9/L) in subjects with documented bone marrow involvement and independent of growth factor support 7 days before assessment. o Platelet count ≥ 50,000 cells/μL (50 x 10^9/L), or ≥ 30,000 cells/μL (30 x 10^9/L) in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded. o Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN). o Total bilirubin ≤ 1.5 x ULN. o Estimated creatinine clearance (ie, estimated glomerular filtration rate [eGFR] using Cockcroft-Gault) ≥ 30 mL/min. • Able to receive all outpatient treatment, all laboratory monitoring, and all radiologic evaluations. • Women who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab in combination with chlorambucil, whichever is longer. • Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study and for 90 days after the last dose of obinutuzumab or chlorambucil, whichever is later. • Men must agree to refrain from sperm donation during the study and for 90 days after the last dose of obinutuzumab or chlorambucil, whichever is later. • Are willing and able to adhere to the study visit schedule, understand and comply with other protocol requirements, and provide written informed consent and authorization to use protected health information."
• • Men and women ≥ 65 years of age, or > 18 and < 65 years of age provided that they meet at least one of the following criteria: o Creatinine clearance 30 to 69 mL/min using the Cockcroft-Gault equation. o A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric (CIRS-G). • ECOG performance status of 0, 1, or 2. • Diagnosis of CD20+ CLL that meets published diagnostic criteria (Hallek 2008) • Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment: o Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL). o Massive (ie, ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly. o Massive nodes (ie, ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy. o Progressive lymphocytosis with an increase of > 50% over a 2-month period or a lymphocyte doubling time (LDT) of < 6 months. LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts (ALC) 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 (30,000/μL), 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. o Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy. o Constitutional symptoms documented in the subject's chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs: - Unintentional weight loss ≥ 10% within the previous 6 months before Screening. - Significant fatigue (ie, ECOG performance status 2; inability to work or perform usual activities). - Fevers higher than 100.5°F or 38.0°C for 2 or more weeks before Screening without evidence of infection. - Night sweats for > 1 month before Screening without evidence of infection. • Meet the following laboratory parameters: o Absolute neutrophil count ≥ 750 cells/μL (0.75 x 10^9/L) or ≥ 500 cells/μL (0.50 x 10^9/L) in subjects with documented bone marrow involvement and independent of growth factor support 7 days before assessment. o Platelet count ≥ 50,000 cells/μL (50 x 10^9/L), or ≥ 30,000 cells/μL (30 x 10^9/L) in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded. o Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN). o Total bilirubin ≤ 1.5 x ULN. o Estimated creatinine clearance (ie, estimated glomerular filtration rate [eGFR] using Cockcroft-Gault) ≥ 30 mL/min. • Able to receive all outpatient treatment, all laboratory monitoring, and all radiologic evaluations. • Women who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib or 18 months after the last dose of obinutuzumab in combination with chlorambucil, whichever is longer. • Men who are sexually active and can beget children must agree to use highly effective forms of contraception during the study and for 90 days after the last dose of obinutuzumab or chlorambucil, whichever is later. • Men must agree to refrain from sperm donation during the study and for 90 days after the last dose of obinutuzumab or chlorambucil, whichever is later. • Are willing and able to adhere to the study visit schedule, understand and comply with other protocol requirements, and provide written informed consent and authorization to use protected health information.