Sequential Regimen of Bendamustin-Debulking Followed by Obinutuzumab, Acalabrutinib and Venetoclax in Patients With Relapsed/Refractory CLL

Summary

CLL2-BAAG is a prospective, open-label, multicenter phase-II trial to evaluate the efficacy and safety of a sequential regimen of debulking with bendamustine followed by induction and maintenance with GA101 (obinutuzumab), acalabrutinib (ACP-196) and venetoclax (ABT-199) in patients with relapsed/refractory CLL.

Timeline

Start

2019-01-14

Primary completion

2021-02-11

Completion

2023-09-26

Publications

• Results Furstenau M, Weiss J, Giza A, Franzen F, Robrecht S, Fink AM, Fischer K, Schneider C, Tausch E, Stilgenbauer S, Ritgen M, Schilhabel A, Bruggemann M, Eichhorst B, Hallek M, Cramer P. Circulating Tumor DNA-Based MRD Assessment in Patients with CLL Treated with Obinutuzumab, Acalabrutinib, and Venetoclax. Clin Cancer Res. 2022 Oct 3;28(19):4203-4211. doi: 10.1158/1078-0432.CCR-22-0433.
• Results Cramer P, Furstenau M, Robrecht S, Giza A, Zhang C, Fink AM, Fischer K, Langerbeins P, Al-Sawaf O, Tausch E, Schneider C, Schetelig J, Dreger P, Bottcher S, Kreuzer KA, Schilhabel A, Ritgen M, Bruggemann M, Kneba M, Stilgenbauer S, Eichhorst B, Hallek M. Obinutuzumab, acalabrutinib, and venetoclax, after an optional debulking with bendamustine in relapsed or refractory chronic lymphocytic leukaemia (CLL2-BAAG): a multicentre, open-label, phase 2 trial. Lancet Haematol. 2022 Oct;9(10):e745-e755. doi: 10.1016/S2352-3026(22)00211-3. Epub 2022 Aug 18.
• Results Furstenau M, Giza A, Weiss J, Kleinert F, Robrecht S, Franzen F, Stumpf J, Langerbeins P, Al-Sawaf O, Simon F, Fink AM, Schneider C, Tausch E, Schetelig J, Dreger P, Bottcher S, Fischer K, Kreuzer KA, Ritgen M, Schilhabel A, Bruggemann M, Stilgenbauer S, Eichhorst B, Hallek M, Cramer P. Acalabrutinib, venetoclax, and obinutuzumab in relapsed/refractory CLL: final efficacy and ctDNA analysis of the CLL2-BAAG trial. Blood. 2024 Jul 18;144(3):272-282. doi: 10.1182/blood.2023022730.

Drugs

Indications