Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

PHASE3CompletedINTERVENTIONAL
Enrollment

416

Participants

Timeline

Start Date

June 15, 2012

Primary Completion Date

June 10, 2019

Study Completion Date

June 10, 2019

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Idelalisib

Idelalisib 150 mg administered orally twice daily

DRUG

Rituximab

Rituximab 375 mg/m\^2 on Day 1, then 500 mg/m\^2 every 28 days administered intravenously for a maximum of 6 infusions

DRUG

Bendamustine

Bendamustine 70 mg/mg\^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions

DRUG

Placebo to match idelalisib

Placebo to match idelalisib administered orally twice daily

Trial Locations (106)

1083

Semmelweis Egyetem, Budapest

1122

Országos Onkológiai Intézet, Budapest

2010

St Vincent's Hospital - Sydney, Darlinghurst

2060

Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg, Antwerp

2250

Gosford Hospital, Gosford

3000

UZ Leuven, Leuven

3168

Monash Medical Centre - Clayton Campus, Clayton

4032

Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Debrecen

4102

Princess Alexandra Hospital, Woolloongabba

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

6009

Sir Charles Gairdner Hospital, Nedlands

6590

Ankara University Medical Faculty, Ankara

6720

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged

7400

Tallian Gyula utca 20-32, Kaposvár

8036

Hospital Clinic de Barcelona, Barcelona

8041

Hospital de la Santa Creu i Sant Pau, Barcelona

9000

UZ Gent, Ghent

9121

Ospedale Oncologico Regionale A. Businco, Cagliari

10000

"Clinical Hospital Dubrava", Zagreb

Klinichki Bolnicki Centar-Zagreb, Zagreb

University Hospital Merkur, Zagreb

10021

Memorial Sloan Kettering Cancer Center, New York

10032

Columbia University Medical Center, New York

10126

Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette, Torino

11030

North Shore University Hospital, Manhasset

11042

Long Island Jewish Medical Center, New Hyde Park

11527

G. Genimatas Hospital, Athens

20125

"Colentina Clinical Hospital", Bucharest

20132

IRCCS Ospedale San Raffaele, Milan

22328

"Fundeni Clinical Institute", Bucharest

25123

Spedali Civili di Brescia, Brescia

26500

University General Hospital of Patras, Pátrai

28033

Hospital Universitario de La Princesa, Madrid

28041

Hospital 12 de Octubre, Madrid

28222

Hospital Universitario Puerta de Hierro, Majadahonda

29414

Charleston Hematology Oncology, Charleston

30322

Winship Cancer Institute at Emory University, Atlanta

31059

Hopital Purpan, Toulouse

32603

University of Florida, Gainesville

34093

Istanbul University Istanbul Medical Faculty, Istanbul

35805

Clearview Cancer Institute, Huntsville

53226

Medical College of Wisconsin, Milwaukee

54511

Hôpitaux de Brabois, Vandoeuvre-lés-Nancy

55239

Ondokuz Mayis University Faculty of Medicine, Samsun

59045

CHRU Lille-Hôpital Claude Huriez, Lille

68100

Centre Hospitalier de Mulhouse, Mulhouse

68198

University of Nebraska Medical Center, Omaha

69373

Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes, Lyon

72015

Centre Jean Bernard - Clinique Victor Hugo, Le Mans

75246

Texas Oncology PA, Dallas

76104

Texas Oncology, Fort Worth

77030

University of Texas MD Anderson Cancer Center, Houston

78731

Texas Oncology, Austin

80218

Rocky Mountain Cancer Center, Denver

90095

UCLA Medical Center, Los Angeles

94010

Hopital Henri Mondor, Créteil

94035

Stanford Cancer Center, Palo Alto

97477

Willamette Valley Cancer Center, Eugene

98109

Seattle Cancer Care Alliance, Seattle

98684

Virginia Cancer Specialists, PC, Vancouver

99202

Cancer Care Northwest, US Oncology, Spokane

115478

Russian Oncology Research Center (N.N. Blokhin), Moscow

193024

Research Institute of Hematology and Blood Transfusion, Saint Petersburg

390039

Ryazan Regional Clinical Hospital, Ryazan

400138

State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1, Volgograd

410028

Saratov State Medical University, Saratov

500152

Emergency County Clinical Hospital Brasov, Brasov

603126

Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko, Nizhny Novgorod

700483

Regional Oncology Institute Iasi, Iași

02115

Dana Farber Cancer Institute, Boston

07962

Summit Medical Group, P.A., Morristown

R3E 0V9

Cancer Care Manitoba, Winnipeg

625 00

Fakultni nemocnice Brno, Brno

500 05

Fakultní nemocnice Hradec Králové, Hradec Králové

708 52

Fakultni nemocnice Ostrava, Ostrava

44 093

CHU Hôtel-Dieu-Service Hématologie, Nantes

Pierre Bénite

Centre Hospitalier Lyon Sud, Pierre-Bénite

Unknown

Mater Misericordiae Hospital, Dublin

Novosibirsk State Regional Clinical Hospital, Novosibirsk

36-200

Szpital Specjalistyczny w Brzozowie, Brzozów

30-510

Malopolskie Centrum Medyczne, Krakow

93-510

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz

20-081

Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin

43-372

Wojewodzki Szpital w Opolu, Opole

02-507

Centralny Szpital Kliniczny MSW w Warszawie, Warsaw

02-781

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Warsaw

1649-035

Hospital Santa Maria, Lisbon

4200-072

"Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)", Porto

08916

Hospital Universitario Germans Trias i Pujol, Badalona

06500

Gazi University Medical Faculty Gazi Hospital, Ankara

B9 5SS

Birmingham Heartlands Hospital, Birmingham

CT1 3NG

Kent and Canterbury Hospital, Canterbury

CF14 4XW

University Hospital of Wales, Cardiff

DT1 2JY

Dorset County Hospital, Dorchester

LS9 7TF

St. James University Hospital, Leeds

L7 8XP

Royal Liverpool University Hospital, Liverpool

EC1A 7BE

St Bartholomews Hospital, London

SE5 9RS

King's College Hospital, London

W12 0NN

Hammersmith Hospital, London

WC1E 6BT

University College London, London

M20 4BX

Christie Hospital, Manchester

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

OX3 7LE

Churchill Hospital, Oxford

TR1 3LJ

Royal Cornwall Hospital, Truro

WV10 0QP

New Cross Hospital, Wolverhampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY