Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
Stopped early · Phase 3
Conditions studied: Chronic Lymphocytic Leukemia
In brief
The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
Key facts
- Study ID
- NCT01980875
- Run by
- Gilead Sciences
- People needed
- 57
- Starts
- 2015-04-21
- Expected to finish
- 2016-05-13
- Last updated by the study team
- 2018-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Sansum Clinic — Santa Barbara, California, United States
- UCLA Jonsson Comprehensive Cancer Center — Santa Monica, California, United States
- Innovative Clinical Research Institute — Whittier, California, United States
- Cancer Center of Central Connecticut — Southington, Connecticut, United States
- Gabrail Cancer Center Research — Canton, Ohio, United States
- Saint Francis Cancer Center — Greenville, South Carolina, United States
- St Vincent Hospital, Sydney — Darlinghurst, New South Wales, Australia
- UZ Ghent- hematology — Ghent, Belgium
- Royal Victoria Regional Health Centre - Simcoe Musk — Barrie, Ontario, Canada
- Centre Hospitalier du Mans — Le Mans, France
- Centre Hospitalier de Perpignan — Perpignan, France
- Szpital Specjalistyczny w Brzozowie, Oddzial Hematologii Onkologicznej — Brzozów, Podkarpackie Voivodeship, Poland
- Malopolskie Centrum Medyczne s.c. — Krakow, Poland
- Wojewódzki Szpital Specjalistyczny w Legnicy — Legnica, Poland
- Wojewodzki Szpital Specjalistyczny, im. M. Kopernika Klinika Hematologii Uniwersytetu Medycznego — Lodz, Poland
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii — Olsztyn, Poland
- Hospital Universitario de Salamanca — Salamanca, Spain
- East Kent Hospitals University NHS Foundation Trust — Canterbury, Kent, United Kingdom
Full record on ClinicalTrials.gov
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