GCLLSG 2016 | Overview of the CLL13 trial: replacing chemotherapy with venetoclax-containing regimens

Julia von Tresckow, MD of University of Cologne, Cologne, Germany, discusses CLL13, a Phase III protocol of the German CLL Study Group aiming to replace chemotherapy with venetoclax-containing regimens (NCT02950051). CLL13 has four arms: standard chemoimmunotherapy as a comparator, venetoclax plus rituximab, venetoclax plus obinutuzumab, and a combination of venetoclax plus ibrutinib plus obinutuzumab. The primary endpoints are: MRD-negativity at 15 months for the comparison of standard chemoimmunotherapy with obinutuzumab plus venetoclax, and progression-free survival (PFS) for the comparison of standard chemoimmunotherapy with a triple combination of venetoclax plus ibrutinib plus obinutuzumab. The CLL13 trial starts in October 2016 in 11 countries. It is a first-line treatment trial designed for fit CLL patients without 17p deletion or TP53 mutation. The objective of the trial is to show that chemotherapy-free regimens are able to show good efficacy and safety and toxicity profile. Recorded at the 2016 International Workshop of the German CLL Study Group (GCLLSG) in Cologne, Germany.