GS-US-312-0118, Efficacy and Safety with Idelalisib in Combination
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Obinutuzumab Compared to Chlorambucil in Combination with Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
IRAS ID
179018
Contact name
Christopher Pocock
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2013-004551-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
The purpose of this study is to provide more information whether giving the combination of idelalisib (IDELA) and obinutuzumab or the combination of chlorambucil and obinutuzumab can benefit patients with Chronic Lymphocytic Leukaemia (CLL). IDELA is still being tested in people; it is considered an investigational drug for this clinical trial.
In past research studies, over 1100 patients with blood cancers, including CLL, have received IDELA, either alone or in combination with other anti-cancer drugs. In some of these studies, IDELA may have helped to control the CLL in some of the patients when given together with other anti-cancer drugs or when given alone.
Up to 306 subjects will be enrolled into the study at about 150 centres in North America, Australia, and Europe.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/0940
Date of REC Opinion
2 Jul 2015
REC opinion
Further Information Favourable Opinion