Clinical Investigation Unit

CLL 17

CLL 17

About the trial

A Phase 3 Multicentre, Randomized, Prospective, Open-label Trial to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated Chronic Lymphocytic Leukaemia (CLL)

Laysummary: In this clinical trial (CLL17 trial), three different treatment arms consisting of ibrutinib and venetoclax plus obinutuzumab in different combinations and with different treatment durations are compared. Currently, it is unclear whether indefinite therapy with ibrutinib and time-limited therapy with the combination of two compounds (i.e., venetoclax plus obinutuzumab or ibrutinib plus venetoclax) are equally effective. To answer this question, a comparison of treatment arms is needed as in the CLL17 trial. Based on the results, it will be possible to decide in the future for which patients which of these therapies is more suitable.

How DCR - CIU supports the trial

DCR - CIU is involved in multiple aspects of the trial conduct: the planning, coordination and conduct of the study visits; collection, processing, storage and shipping of biological samples, intravenous IMP administration and accountability, maintenance of the Investigator Site File, and data entry.

Dr. med. Martin Andres, Universitätsklinik für Hämatologie und Hämatologisches Zentrallabor

German CLL Study Group