Spots Global Cancer Trial Database for Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
Official 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
Study ID: NCT01980875
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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 Cedex 9, , France
Szpital Specjalistyczny w Brzozowie, Oddzial Hematologii Onkologicznej, Brzozow, Podkarpackie, 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
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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