The trial is expected to compare a blend of Pixantrone plus Rituximab to a combination of Gemcitabine plus Rituximab in patients with relapsed or refractory DLBCL who have received one to three prior lines of therapy.
PIX-R trial is aiming to recruit around 350 patients.
The co-primary endpoints for the PIX-R trial are PFS and OS with secondary endpoints including overall response rate (ORR) (ORR equals complete responses plus partial responses), complete response rate and safety.
CTI chief medical officer Jack Singer said they are pleased to open enrollment for this study and have been in communication with leading cancer clinical sites that are enthusiastic about participating in the study largely based on the positive results of our previous study, PIX 301, in relapsed/refractory aggressive non-Hodgkin’s lymphoma patients.
"There is an unmet medical need in this patient group, and the lack of any FDA approved drug for these patients should generate strong interest in the trial from both the patients and physicians," Singer said.