Phase I Dose-escalation Study to Investigate the Safety and Tolerability of ONO-4059 Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma and/or Chronic Lymphocytic Leukaemia.
An open-label, multi-centre, non-randomised phase I dose-escalation study to investigate the
safety and tolerability of ONO-4059 given as monotherapy in patients with
relapsed/refractory Non-Hodgkin's lymphoma (NHL) and relapsed/refractory chronic lymphocytic
leukaemia (CLL). Non-Hodgkin's lymphoma are a heterogeneous group of malignancies which have
a varied clinical and biological features. Leukaemia is a type of cancer of the blood or
bone marrow characterized by an abnormal increase of immature white blood cells. Chronic
lymphocytic leukaemia (CLL) is the most common type of adult leukaemia affecting the blood
and bone marrow.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1. Safety and tolerability and the incidence of dose limiting toxicities (DLTs). DLTs will be assessed within the first 28 days from receiving the first dose of ONO-4059.
Frequency, severity and relatedness of AEs.
6 - 12 months
Ono Pharmaceutical Co. Ltd
United Kingdom: Medicines and Healthcare Products Regulatory Agency