Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

PHASE3TerminatedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

April 21, 2015

Primary Completion Date

May 13, 2016

Study Completion Date

May 13, 2016

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Idelalisib

150 mg tablet administered orally twice daily

DRUG

Chlorambucil

2 mg tablets administered at a dose of 0.5 mg/kg orally every other week for a total of 12 doses

DRUG

Obinutuzumab

1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks

Trial Locations (18)

2010

St Vincent Hospital, Sydney, Darlinghurst

9000

UZ Ghent- hematology, Ghent

29607

Saint Francis Cancer Center, Greenville

37007

Hospital Universitario de Salamanca, Salamanca

44718

Gabrail Cancer Center Research, Canton

72037

Centre Hospitalier du Mans, Le Mans

90404

UCLA Jonsson Comprehensive Cancer Center, Santa Monica

90603

Innovative Clinical Research Institute, Whittier

93105

Sansum Clinic, Santa Barbara

06489

Cancer Center of Central Connecticut, Southington

L4M 6M2

Royal Victoria Regional Health Centre - Simcoe Musk, Barrie

66046-BP 49954

Centre Hospitalier de Perpignan, Perpignan

36-200

Szpital Specjalistyczny w Brzozowie, Oddzial Hematologii Onkologicznej, Brzozów

30-510

Malopolskie Centrum Medyczne s.c., Krakow

59-220

Wojewódzki Szpital Specjalistyczny w Legnicy, Legnica

93-510

Wojewodzki Szpital Specjalistyczny, im. M. Kopernika Klinika Hematologii Uniwersytetu Medycznego, Lodz

10-228

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii, Olsztyn

CT1 3NG

East Kent Hospitals University NHS Foundation Trust, Canterbury

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY