Title: A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine and Rituximab (BR) in Fit Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation (CRISTALLO)
Study Director: Hoffmann-La Roche
Description: Investigators are conducting a phase 3 study to compare venetoclax plus obinutuzumab with rituximab-based regimens in fit patients with previously untreated chronic lymphocytic leukemia (CLL) without del(17p) or TP53 mutation.
Trial participants are randomly assigned to receive venetoclax plus obinutuzumab or 1 of 2 rituximab-based regimens — bendamustine plus rituximab (BR) or fludarabine, cyclophosphamide, and rituximab (FCR). Patients in the venetoclax-obinutuzumab arm receive 12 cycles of treatment, and those in the FCR/BR arm receive 6 cycles of treatment.
The primary endpoint is minimal residual disease response rate in the first 140 participants recruited. Key secondary endpoints include progression-free survival, event-free survival, overall survival, and safety.
To be eligible for this study, patients must have previously untreated, documented CLL according to International Workshop on Chronic Lymphocytic Leukemia criteria. For a complete list of eligibility criteria, please refer to the reference.
This study is sponsored by Hoffmann-La Roche.
Clinicaltrials.gov. A study to compare the efficacy and safety of a combined regimen of venetoclax and obinutuzumab versus fludarabine, cyclophosphamide, and rituximab (FCR)/ bendamustine and rituximab (BR) in fit patients with previously untreated chronic lymphocytic leukemia (CLL) without del(17p) or TP53 mutation (CRISTALLO). NCT04285567. Accessed December 15, 2021.