BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)

Exclusion Criteria

• •1. Treatment with anti Cluster of Differentiation (CD) 20 therapy within 4 weeks, or alemtuzumab within 8 weeks, or any cytotoxic antileukemia therapy within 2 weeks, Ibrutinib or Idelalisib within 1 week prior to the first administration of the trial drug.
• •2. Prior allogeneic stem cell transplantation.
• •3. Active autoimmune haemolytic anemia.
• •4. Active autoimmune thrombocytopenia.
• •5. Known transformation to an aggressive B-cell malignancy.
• •6. Concurrent treatment with relevant doses of systemic glucocorticosteroids.
• •7. Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).
• •8. Aspartate aminotransferase or alanine aminotransferase \> 2.5 x upper limit of normal.
• •9. Total bilirubin \> 1.5 x upper limit of normal.
• •10. Absolute Neutrophil Count \< 1.000/µl.
• •11. Platelets \< 25.000/µL.
• •12. Estimated Glomerular Filtration Rate \<45 mL/min.
• •13. Proteinuria Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher.
• •14. Significant concurrent disease.
• •15. Any infectious disease requiring treatment at the time of enrolment or within the previous 2 weeks.
• •16. Hepatitis B or C.
• •17. Human Immunodeficiency Virus (HIV) infection.
• •18. Cytomegalovirus (CMV) viremia.
• •19. Women of childbearing potential not using a highly effective method of birth control during the trial until one year after the last dose.
• •20. Pregnancy or breast feeding.
• •21. Known or suspected active alcohol or drug abuse.
• •22. Treatment with another investigational drug within the past four weeks before start of therapy or concomitantly with this trial.
• •23. Prior treatment with BI 836826.
• •24. Patients unable to comply with the protocol