BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)
Condition: Leukemia, Lymphocytic, Chronic, B-Cell
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: BI 836826
Intervention description: Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion.
Intervention MeSH terms: BI 836826
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two
      prior treatment regimens may be enrolled in this trial. The trial will examine whether
      monotherapy with BI 836826 is safe and tolerable at escalating dose levels.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of relapsed or refractory chronic lymphocytic leukaemia.

          2. At least two prior treatment regimens for chronic lymphocytic leukaemia.

          3. At least one criterion for active disease as defined by the International Workshop on
             CLL.

          4. Absolute lymphocyte count lower than 200 x 10^9/l .

          5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2.

          6. Age 18 years or older.

          7. Written informed consent which is consistent with International Conference on
             Harmonisation - Good Clinical Practice (ICH-GCP) guidelines and local legislation.

        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