Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

445

Participants

Timeline

Start Date

December 31, 2014

Primary Completion Date

August 17, 2018

Study Completion Date

August 31, 2025

Conditions
Lymphocytic Leukemia, Chronic
Interventions
DRUG

Chlorambucil

Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.

DRUG

Venetoclax

Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.

DRUG

Obinutuzumab

Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6

Trial Locations (112)

1090

Medizinische Universität Wien, Vienna

1140

Hanusch-Krankenhaus, Vienna

1431

"University Multiprofile Hospital For Active Treatment Sveti Ivan Rilski EAD", Sofia

1871

Liverpool Hospital, Liverpool BC

2100

Rigshospitalet, København Ø

2485

Tweed Hospital, Tweed Heads

2730

Herlev Hospital, Herlev

3000

MHAT Hristo Botev, Vratsa

3010

Inselspital Bern, Bern

3076

The Northern Hospital, Epping

3128

Box Hill Hospital, Box Hill

3168

Monash Medical Centre, Melbourne

4000

Sjaellands Universitetshospital, Roskilde, Roskilde

4002

"UMHAT Sveti Georgi Plovdiv - Clinic of Oncology and Hematology", Plovdiv

University Hospital Sv.Georgi Clnic of Hematology, Plovdiv

4102

Princess Alexandra Hospital Woolloongabba, Woolloongabba

4442

Midcentral District Health Board, Palmerston North

4814

The Townsville Hospital, Douglas

5000

Royal Adelaide Hospital, Adelaide

5035

Ashford Cancer Centre Research, Ashford

5036

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroc?awiu, Wroclaw

5800

UMHAT Dr Georgi Stranski, Pleven

6000

Luzerner Kantonsspital, Hämatologie, Lucerne

6012

Wellington Hospital, Wellington

6020

Tiroler Landeskrankenanstalten Ges.M.B.H., Innsbruck

7100

Sygehus Lillebælt, Vejle, Vejle

8011

Canterbury Health Laboratories, Christchurch

8091

Universitätsspital Zürich Medizin Hämatologie, Zurich

9351

Wojewódzki Szpital Specjalistyczny im. Miko?aja Kopernika, Lodz

10000

University Hospital Center Zagreb, Zagreb

University Hospital Merkur Clinic for Internal Medicine/ Hematology, Zagreb

10126

AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette, Torino

13353

Charite - Campus Virchow-Klinikum, Berlin

Charite - Universitätsmedizin Berlin, Berlin

13419

North Estonia medical Centre, Tallinn

14000

Institut d'Hématologie de Basse Normandie, Caen

15236

Klinikum Frankfurt/Oder, Frankfurt (Oder)

20132

Ospedale San Raffaele, Milan

28006

Hospital Universitario de la Princesa, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Univ. 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

30174

Ospedale dell' Angelo, Venezia Mestre

30322

Winship Cancer Institute, Atlanta

31008

Complejo Hospitalario de Navarra, Pamplona

33098

Brüderkrankenhaus St. Josef Paderborn, Paderborn

34295

Hôpital Saint Eloi, Montpellier

38043

CHU de Grenoble, Grenoble

38320

Hospital Universitario de Canarias, San Cristóbal de La Laguna

41013

Hospital Universitario Virgen del Rocio, Seville

41063

Kliniken Maria Hilf GmbH Innere Medizin I, Mönchengladbach

44093

Hopital Hotel Dieu Et Hme, Nantes

44100

Arcispedale S. Anna, Ferrara

44625

Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte, Herne

45004

Complejo Hospitalario de Toledo- H. Virgen de la Salud, Toledo

45122

Universitätsklinikum Essen, Essen

46010

Hospital Clinico Universitario de Valencia, Valencia

50937

Universitätsklinikum Köln, Cologne

51014

Tartu Uni Hospital, Tartu

52074

Uniklinik RWTH Aachen, Aachen

56068

Praxisklinik für Hämatologie und Onkologie Koblenz, Koblenz

60426

Ingalls Memorial Hospital, Harvey

69120

Universitaetsklinikum Heidelberg, Heidelberg

69373

Centre Leon Berard, Lyon

70199

Marienhospital, Stuttgart

70376

Robert-Bosch-Krankenhaus, Stuttgart

72000

Centre Jean Bernard, Le Mans

72076

Universitätsklinikum Tübingen, Tübingen

73557

Klinikum Schwäbisch Gmünd, Mutlangen

73730

Klinik Esslingen, Esslingen am Neckar

75475

Hopital Saint Louis, Paris

76038

Centre Henri Becquerel, Rouen

79106

Uniklinikum Freiburg, Freiburg im Breisgau

80230

Hospital General de Culiacan, Culiacán

80804

München Klinik Schwabing, München

83056

CH de Toulon Hôpital Sainte Musse, Toulon

83177

Klinikum der Universität München, Campus Großhadern, München

85234

Banner MD Anderson Cancer Center, Gilbert

89081

Universtitätsklinikum Ulm, Ulm

93049

Krankenhaus Barmherzige Bruder Regensburg, Regensburg

94000

Hopital Henri Mondor, Créteil

94805

Institut Gustave Roussy - Hematologie, Villejuif

420029

Republican Clinical Oncologic Dispensary of Republic Of Tatarstan, Kazan'

440071

Penza Regional Oncology Dispensary, Penza

540136

Spitalul Clinic Judetean de Urgenta Targu-Mures, Târgu Mureş

603126

Regional Clinical Hospital N.A. Semashko, Nizhny Novgorod

700483

Institutul Regional de Oncologie Iasi, Iași

33612-9497

Moffitt Cancer Center, Tampa

48202-2689

Henry Ford Hospital, Detroit

C1181ACH

Hospital Italiano, Buenos Aires

90035-903

Hospital das Clinicas - UFRGS, Porto Alegre

01236-030

Instituto de Ensino e Pesquisa Sao Lucas - IEP, São Paulo

05403-000

Hospital das Clinicas - FMUSP, São Paulo

T2N 4N2

Arthur J.E. Child Comprehensive Cancer Center, Calgary

B3H 2Y9

Queen Elizabeth II Health Sciences Centre, Halifax

H3T 1E2

Jewish General Hospital, Montreal

01307

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf, Dresden

"Uniklinikum Carl Gustav Carus;Med. Klinik 1", Dresden

00168

Uni Cattolica, Rome

05100

Az. Osp. S. Maria, Terni

Unknown

Dunedin Hospital, Dunedin

41-500

Samodzielny Public Zaklad, Chorzów

76-200

Wojewodzki Szpital Specjalistyczny im. J. Korczaka, Słupsk

022328

Fundeni Clinical Inst., Bucharest

08003

Hospital del Mar, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clínic i Provincial, Barcelona

B9 5SS

Birmingham Heartlands Hospital, Birmingham

PE21 9QS

Boston Pilgrim Hospital, Boston,Lincolnshire

EH4 2XU

Western General Hospital, Edinburgh

LN2 5QY

Lincoln County Hospital, Lincoln

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southhampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

collaborator

German CLL Study Group

OTHER

lead

Hoffmann-La Roche

INDUSTRY