Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib

Inclusion Criteria

• •Diagnosis of Chronic Lymphocytic Leukemia (CLL) established according to International Workshop Chronic Lymphocytic Leukemia (IWCLL) criteria.
• •Relapsed or refractory CLL pre-treated with at least one prior line of systemic therapy for CLL.
• •Indication for treatment consistent with IWCLL criteria, i.e. at least one of the following criteria should be met
• •Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia.
• •Massive or progressive or symptomatic splenomegaly.
• •Massive nodes or progressive or symptomatic lymphadenopathy.
• •Progressive lymphocytosis in the absence of infection, with an increase in blood Absolute Lymphocyte Count (ALC) \>=50% over a 2-month period, or a lymphocyte doubling time (LDT) of \<6 months (as long as initial ALC was \>=30000/µl).
• •Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy.
• •Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs:
• •unintentional weight loss of 10% or more within the previous 6 months
• •significant fatigue
• •fevers higher than 100.5°F or 38.0°C for \>=2 weeks without other evidence of infection
• •night sweats for \> 1 month without evidence of infection
• •Clinically quantifiable disease burden defined as at least one of the following:
• •either ALC \>10 000/µL, or
• •measurable lymphadenopathy
• •quantifiable bone marrow infiltration documented in a bone marrow biopsy during screening
• •Resolution of all clinically relevant acute non-hematologic toxic effects of any prior antitumor therapy resolved to Grade \<=1
• •Baseline laboratory data as defined as:
• •Hemoglobin (Hb): \>=8g/dL Absolute Neutrophil Count (ANC): \>=1000/µL Platelet (PLT): \>=25000/µL Glomerular Filtration Rate (GFR) or Creatinine Clearance: \>=30ml/min Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): \<3 x Upper Limit of Normal (ULN) Bilirubin - total: \<1.5 x ULN Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) or International Normalized Ratio (INR): \<=1.5 x ULN PT \<=1.5 x ULN, INR \<=1.5
• •Male or female patients. Women of childbearing potential must agree to use highly effective methods of birth control during the trial and for at least 1 year after the last dose of BI 836826 and 1 month after the last dose of ibrutinib.
• •Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
• •Age 18 years and older
• •Eligible and able to secure sourcing for ibrutinib
• •Written Informed Consent