A prospective, randomized, unblinded, multicenter, phase III study comparing the efficacy and safety of ibrutinib monotherapy versus time-limited therapy with venetoclax plus obinutuzumab or ibrutinib plus venetoclax in patients with previously untreated chronic lymphocytic leukemia (CLL) - CLL17
Summary of the study
In this clinical trial (CLL17 trial), three different treatment arms consisting of ibrutinib and venetoclax as well as obinutuzumab in different combinations and with different treatment durations are being compared with each other. It is currently unclear whether an indefinite therapy with ibrutinib and a time-limited therapy with the combination of two drugs (i.e. venetoclax plus obinutuzumab or ibrutinib plus venetoclax) are equally effective. To answer this question, a comparison of the treatment arms as in the CLL17 study is required. Based on the results, it will be possible to decide in future which of these therapies is more suitable for which patients. Continuous therapy with ibrutinib is approved for the treatment of CLL in the EU and Switzerland. The time-limited therapy with the combination venetoclax + obinutuzumab is approved in the EU but not in Switzerland. The time-limited therapy with ibrutinib + venetoclax is not yet an approved therapy combination. All patients included in this study will receive one of the three treatment arms. Which treatment you receive is decided at random by computer selection (this procedure is called "randomization"). The probability of being allocated to a particular treatment arm is 33%. You will either receive treatment with ibrutinib, with venetoclax and obinutuzumab or with ibrutinib and venetoclax.
(BASEC)