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Brief Title: Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients With Relapsed/Refractory CLL
Official Title: A Prospective, Open-label, Multicenter Phase-II Trial to Evaluate the Efficacy and Safety of a Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients With Relapsed/Refractory CLL (CLL2-BZAG Protocol)
Study ID: NCT04515238
Brief Summary: CLL2-BZAG is a prospective, open-label, multicenter phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by obinutuzumab (GA101), zanubrutinib (BGB-3111) and venetoclax (ABT-199) in patients with relapsed/refractory CLL.
Detailed Description: In the CLL2-BZAG trial will be included a total of 40 patients with relapsed or refractory CLL in need of treatment. This trial will evaluate a debulking with two cycles bendamustine (only for patients with a high tumor load), followed by an induction and maintenance treatment with obinutuzumab, zanubrutinib and venetoclax in patients with relapsed/refractory CLL. Thus, this trial combines one established (chemotherapy) and three novel, synergistic (antibody, Bruton's tyrosine kinase(BTK)-inhibitor and Bcl-2 antagonist) principles of action in order to achieve deep and long lasting remissions with a short duration of treatment. Additionally, this trial has an extensive accompanying scientific program aiming at a better understanding of the kinetics of response and clonal evolution of CLL.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hamatologische/Onkologische Gemeinschaftspraxis, Augsburg, , Germany
Onkologische Schwerpunktpraxis, Esslingen, , Germany
Evangelische Krankenhaus Hamm, Hamm, , Germany
Universitaetskliniken des Saarlandes, Homburg, , Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel, Kiel, , Germany
Universitätsklinik Köln, Köln, , Germany
Klinikum Rechts der Isar - Technische Universitaet Muenchen, Munich, , Germany
Stauferklinikum Schwaebisch-Gmuend, Mutlangen, , Germany
KH Kliniken Maria Hilf, Mönchengladbach, , Germany
Universitätsklinik Ulm, Ulm, , Germany
Hämatologisch Onkologische Schwerpunktpraxis, Würzburg, , Germany
Name: Paula Cramer, Dr. med.
Affiliation: German CLL Study Group
Role: PRINCIPAL_INVESTIGATOR