SHS_492288 PAGJ CINA 15183

Open Label 1b/2a Trial of a Combination of IPH2201 and Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Combination study of IPH2201 with Ibrutinib in relapsed or refractory Chronic Lymphocytic Leukemia (CLL) patients in 2 parts: phase 1b : a 3+3 design to assess the Maximum Tolerated Dose (MTD); phase 2a: to evaluate the anti-leukemic activity of the combination.

Inclusion Criteria:
Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL). Relapsed of refractory CLL. CLL requiring treatment. At least one line of previous treatment. Age > = 18 years. Eastern Cooperative Oncology Group performance status of 0-2. Life expectancy > = 3 months. Adequate liver and renal function.

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. Current active infectious disease. History of another malignancy within 3 years. History of allogeneic stem cell or solid organ transplantation.
Phase I/II
John Pagel, M.D.
Innate Pharma
Paul Wisniewski
  • Swedish Medical Center