Last updated on January 2019

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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Gilead Study Team

Mutlangen, Germany

Gilead Study Team

Ravensburg, Germany

Gilead Study Team

Ulm, Germany

Gilead Study Team

Augsburg, Germany

Gilead Study Team

Erlangen, Germany

Gilead Study Team

Wurzburg, Germany

Gilead Study Team

Frankfurt, Germany

Gilead Study Team

Koln, Germany

Gilead Study Team

Paderborn, Germany

Gilead Study Team

Neunkirchen, Germany

Gilead Study Team

Leipzig, Germany

Gilead Study Team

Kiel, Germany

Gilead Study Team

Regensburg, Germany

Gilead Study Team

Luebeck, Germany

Gilead Study Team

Muenchen, Germany

Gilead Study Team

Mannheim, Germany

Gilead Study Team

Tübingen, Germany

Gilead Study Team

München, Germany

Gilead Study Team

Gießen, Germany

Gilead Study Team

Mönchengladbach, Germany

Recruitment Status: Closed


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