The clinical trial aims to assess the efficacy and safety of two drug products.
The study will be conducted in several countries. Men and women aged >18 will take part in this study and will be randomly allocated to four equal treatment arms. The study will include a non-binding interim analysis and is expected to last for 24 months.
Chronic lymphocytic leukemia affects mainly older adults, accounts for one third of all diagnosed cases of leukemia, and is characterized by the accumulation of clonal mature B lymphocytes in the blood, bone marrow, and secondary lymphoid tissues. This is a heterogeneous disease, with several higher risk cytogenetic abnormalities which are generally more difficult to treat. Chronic lymphocytic leukemia remains an incurable disease, and many patients will progress and eventually die from their disease. Furthermore, patients with higher risk of cytogenetic abnormalities still present with a less than optimal response to approved therapies and shorter duration of response and progression free survival. As such, there is a pressing need for new, innovative, targeted therapies for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia, especially those with cytogenetic abnormalities.
OCT team is responsible for the conduct of this study in Russia, Ukraine and Bulgaria, enrollment of 200 patients (out of 700 screened), selection of investigational sites and regional laboratories, import of the study medication, purchase of the reference medication, and interaction with Russian regulator. Investigators meetings in Bulgaria and Ukraine are expected to be held in the beginning of March, with one meeting already successfully conducted in Russia.
Currently there is a very small number of effective treatment solutions available in this therapeutic area. So far, the best risk-benefit profile has been demonstrated for the drugs investigated in this study.