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.
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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