Dr. Ghia on the Design of the CAPTIVATE Study in Treatment-Naïve CLL

Paolo Ghia, MD, PhD, full professor, Medical Oncology, head, Strategic Research Program on CLL, Università Vita Salute San Raffaele, deputy director, Division of Experimental Oncology, San Raffaele Scientific Institute, discusses the design of the phase 2 CAPTIVATE study (NCT02910583) in treatment-naïve chronic lymphocytic leukemia (CLL).

The CAPTIVATE trial treated patients with treatment-naïve CLL with 3 cycles of ibrutinib (Imbruvica) monotherapy, followed by 12 cycles of ibrutinib plus venetoclax (Venclexta), Ghia explains. Following the 12-month period, patients were randomized based on if they had achieved their confirmed undetectable minimal residual disease (uMRD) status, Ghia says. 

The MRD-guided protocol randomized patients with confirmed uMRD status 1:1 to continue on ibrutinib or receive placebo. Patients without confirmed uMRD were randomized 1:1 to ibrutinib or ibrutinib/venetoclax, Ghia concludes.