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 =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 =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): =2 years after end of cancer treatment.
• Active, uncontrolled autoimmune cytopenia. Patients with autoimmune cytopenia which is controlled with corticosteroids at doses of = 6 months and without indication for anti-coagulation
• Requirement for chronic anticoagulation with warfarin or with direct oral anticoagulants at the time of screening.
• Chronic treatment (i.e. >7 days) with a strong Cytochrome P450 (CYP3A) inhibitor which cannot be terminated prior to the first dose of ibrutinib.
• Unstable angina pectoris, uncontrolled hypertension, uncontrolled asthma or other pulmonary disease
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Further Exclusion criteria apply