A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

PHASE3CompletedINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

October 31, 2013

Study Completion Date

April 30, 2014

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Idelalisib

Idelalisib 150 mg tablet administered orally twice daily

DRUG

Rituximab

Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter

DRUG

Placebo to match idelalisib

Placebo to match idelalisib administered orally twice daily

Trial Locations (72)

1307

Gemeinschaftspraxis Hämatologie-Onkologie, Dresden

9121

Ospedale Oncologico Regionale A. Businco, Cagliari

10021

Weill Cornell Medical College, New York

10032

Columbia University Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

11042

Long Island Jewish Medical Center, New Hyde Park

20057

Georgetown University Medical Center Lombardi Cancer Center, Washington D.C.

20132

Ospedale San Raffaele S.r.l., Milan

22031

Virginia Cancer Specialists, PC, Fairfax

24014

Oncology and Hematology Associates of Southwest Virginia, Inc, Roanoke

29605

Cancer Centers of the Carolinas, Greenville

30322

Winship Cancer Institute at Emory University, Atlanta

31059

Hopital Purpan, Toulouse

32610

University of Florida, Gainesville

33435

Collaborative Medical Research Corporation, Boynton Beach

Collaborative Research Group LLC, Boynton Beach

33705

Florida Cancer Specialists, St. Petersburg

33916

Florida Cancer Specialists, Fort Myers

35019

Hôpital Pontchaillou, Rennes

35805

Clearview Cancer Institute, Huntsville

37203

Sarah Cannon Cancer Center, Nashville

50937

Universitätsklinikum Köln, Cologne

53226

Medical College of Wisconsin, Milwaukee

59045

Centre Hospitalier Régional Universitaire de Lille (CHRU), Lille

60611

Northwestern University, Chicago

66538

Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth, Neunkirchen

68100

Hôpital Emile Muller, Mulhouse

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

73557

Stauferklinikum Schwäb. Gmünd, Mutlangen

76038

Centre Henri Becquerel, Rouen

76104

Texas Oncology, P.A., Fort Worth

77030

M.D. Anderson Cancer Center, Houston

78217

Cancer Care Network of South Texas, San Antonio

80218

Rocky Mountain Blood and Marrow Transplant Program, Denver

Rocky Mountain Cancer Center, Denver

85704

Arizona Oncology Associates, Tucson

89081

Universitätsklinikum Ulm, Ulm

90404

UCLA, Santa Monica

91052

Internistische Gemeinschaftspraxis, Erlangen

92093

University of California, San Diego- Moores Cancer Center, La Jolla

93030

Ventura County Hematology Oncology Specialists, Oxnard

94010

Hôpital Henri Mondor, Créteil

94305

Stanford Cancer Center, Stanford

97062

Northwest Cancer Specialists, PC, Tualatin

97477

Willamette Valley Cancer Center, Springfield

98902

Yakima Valley Memorial Hospital / North Star Lodge, Yakima

07601

Hackensack University Medical Center, Hackensack

07962

Hematology Oncology Associates of Northern New Jersey, Morristown

98109-1024

Seattle Cancer Care Alliance, Seattle

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

CB2 0QQ

Addenbrooke's Hospital, Cambridge

CF14 4XW

University Hospital of Wales, Cardiff

HU10 6ED

Castle Hill Hospital, Cottingham

DT1 2JY

Dorset County Hospital, Dorchester

EH4 2XU

Western General Hospital, Edinburgh

HA1 3UJ

Northwick Park Hospital, Harrow

LS9 7TF

St James's University Hospital, Leeds

L7 8XP

Royal Liverpool University Hospital, Liverpool

SE5 9RS

King's College Hospital, London

W12 0NN

Hammersmith Hospital, London

W1G 6AD

Sarah Cannon Research Institute UK, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

BR6 8ND

Princess Royal University Hospital, Orpington

SP2 8BJ

Salisbury District Hospital, Salisbury

SO16 6YD

Southampton General Hospital, Southampton

SM2 5PT

Royal Marsden Hospital, Sutton

SN3 6BB

Great Western Hospital, Swindon

TQ2 7AA

Torbay District General Hospital, Torquay

TR1 3LJ

Royal Cornwall Hospital, Truro

WV10 0QP

New Cross Hospital, Wolverhampton

BA21 4AT

Yeovil District Hospital, Yeovil

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01539512 - A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) | Biotech Hunter | Biotech Hunter