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

Summary

This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale \[CIRS\]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).

Timeline

Start

2020-05-28

Primary completion

2024-03-19

Completion

2025-03-19

Publications

• Sharman JP, Laurenti L, Ferrant E, Casado Montero LF, Mulligan SP, Harrup R, Opat S, Ibatici A, Marasca R, Sportoletti P, Thadani-Mulero M, Cazares O, Huang W, Jiang Y, Clark E, Jin HY, Boyer M, Morschhauser F. Fixed-duration VenO vs FCR/BR in fit patients with untreated CLL: primary analysis of the phase 3 CRISTALLO trial. Blood. 2026 Jun 11;147(24):2895-2904. doi: 10.1182/blood.2025030630.

Drugs

Indications