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

Stopped early · Phase 1/Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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

Key facts

Study ID

NCT02557516

Run by

Innate Pharma

People needed

22

Starts

2015-11-09

Expected to finish

2019-09-25

Last updated by the study team

2019-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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