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

• Status: Terminated
• Trial end date: 2019-09-25
• Target enrollment: 0
• Participant gender: All

Summary

Combination study of monalizumab (IPH2201) with Ibrutinib in relapsed, refractory or previously untreated Chronic Lymphocytic Leukemia (CLL) patients in 2 parts :

• phase 1 : a 3+3 design to assess the Maximum Tolerated Dose (MTD)

• phase 2: to evaluate the anti-leukemic activity of the combination

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innate Pharma

Criteria

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