In this study, efficacy and safety of 2 regimens that combine the CD3-CD20 T cell engager epcoritamab with venetoclax will be tested in relapsed/refractory CLL and SLL patients. The trial starts with phase I part to establish the recommended dose level (RDL) of epcoritamab in the combination with venetoclax for the phase II trial.
Documented relapsed or refractory CLL or SLL (SLL in phase II part only) following at least one systemic 1st-line treatment
Requiring treatment according to IWCLL criteria (appendix A);
Age at least 18 years;
ECOG/WHO performance status 0-2;
Active CLL/SLL directed therapy within the last 14 days;
Prior treatment with a CD3 × CD20 bispecific antibody or CAR T-cell therapy
Transformation of CLL (Richter's transformation);
Prior allogeneic stem cell transplantation and/or solid organ transplantation;
Stichting Hemato-Oncologie voor Volwassenen Nederland
Lead sponsor
Nordic CLL Study Group
Collaborator
German CLL Study Group
Collaborator