Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL

Inclusion Criteria:

Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
Relapsed, refractory or previously untreated CLL
CLL requiring treatment; patients must be eligible for ibrutinib therapy
Age > = 18 years
Eastern Cooperative Oncology Group performance status of 0-2
Life expectancy > = 3 months
Adequate liver and renal function
Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study participation
Ability to understand a written informed and consent document
Signed informed consent prior to any protocol-specific procedures

Exclusion Criteria:

Patients who have previously received ibrutinib or another inhibitor of Bruton's tyrosine kinase (BTK)
History of allergic reactions attributed to compounds or similar chemical or biological composition to ibrutinib
Central nervous system involvement of the CLL
Abnormal hematological function which is not due to bone marrow failure related to the CLL
Patients requiring a treatment by oral vitamin K antagonists
Serious uncontrolled medical disorder
Medical condition or organ system dysfunction which, in the investigator opinion, could interfere with absorption or metabolism of ibrutinib
Moderate or severe hepatic impairment
Active auto-immune disease
Abnormal cardiac status
Pregnant women are excluded from study
Current active infectious disease
History of another malignancy within 3 years
History of allogeneic stem cell or solid organ transplantation