Last updated on June 2018

Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)


Brief description of study

The primary objective of this study is to determine the preliminary efficacy and safety of the combination of tirabrutinib and idelalisib with obinutuzumab in adults with relapsed or refractory chronic lymphocytic leukemia (CLL).

The study has a 6 patient per arm safety run-in to evaluate safety prior to the enrollment of subsequent participants. The primary objective is evaluation of efficacy with the secondary objective evaluation of safety and evaluation of additional parameters of efficacy. The treatment period is adaptive, with a duration of active treatment up to two years and a total follow-up on study of 5 years for time-dependent outcome variables.

Clinical Study Identifier: NCT02968563

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