A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

PHASE3CompletedINTERVENTIONAL
Enrollment

389

Participants

Timeline

Start Date

March 17, 2014

Primary Completion Date

May 8, 2017

Study Completion Date

August 3, 2022

Conditions
Chronic Lymphocytic Leukemia
Interventions
DRUG

Bendamustine

Bendamustine will be administered at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.

DRUG

Venetoclax

"Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first.~R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy."

DRUG

Rituximab

"Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.~R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle."

Trial Locations (111)

1060

Baxter Healthcare, Mount Wellington

1088

Semmelweis Egyetem, Budapest

1090

Medizinische Universität Wien, Vienna

1122

Orszagos Onkologiai Intezet, Budapest

1160

Klinik Ottakring, Vienna

1200

Cliniques Universitaires Saint-Luc; Hematology, Brussels

1309

North Shore Hospital; Haematolgy, Auckland

2060

ZNA Antwerpen; Department Hematology, Antwerp

2065

The Canberra Hospital, Garran

2100

Rigshospitalet, København Ø

2139

Concord Repatriation General Hospital, Concord

2217

St George Hospital, Kogarah, New South Wales

2730

Herlev Hospital, Herlev

3000

UZ Leuven; Department Hematology, Leuven

3050

Royal Melbourne Hospital, Parkville

3051

Peter MacCallum Cancer Center, North Melbourne

3149

Slade Health Pharmacy, Mount Waverley

3168

Monash Medical Centre; Haematology, Melbourne

3199

Frankston Hospital, Frankston

3508

UMC Utrecht, Utrecht

4000

Sjællands Universitetshospital, Roskilde, Roskilde

4012

Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika, Debrecen

4102

Princess Alexandra Hospital, Woolloongabba

5000

Royal Adelaide Hospital, Adelaide

Odense Universitetshospital, Odense C

5020

LKH - Universitätsklinikum der PMU Salzburg, Salzburg

5042

Flinders Medical Centre, Bedford Park

5530

CHU UCL Mont-Godinne, Mont-godinne

6009

The Perth Blood Institute, Nedlands

6020

Medizinische Universität Innsbruck, Innsbruck

6591

The Catholic University of Korea Seoul St. Mary?s Hospital, Seoul

6720

Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp., Szeged

7000

Royal Hobart Hospital, Hobart

7100

Sygehus Lillebælt, Vejle, Vejle

7624

Somogy Megyei Kaposi Mor Oktato Korhaz, Pécs

8011

Christchurch Hospital NZ, Christchurch

8500

AZ Groeninge, Kortrijk

8800

AZ Delta (Campus Rumbeke), Roeselare

10002

National Taiwan University Hospital, Taipei

10021

Memorial Sloan Kettering Cancer Center; Clinical Trials Office, New York

10032

Perlmutter Cancer Center NYU Langone Health, New York

10126

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

16132

Azienda Ospedaliero Universitaria San Martino, Genoa

20132

Ospedale San Raffaele, Milan

20162

Asst Grande Ospedale Metropolitano Niguarda; SC Farmacia Ospedale, Milan

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo

28041

Hospital Universitario 12 de Octubre, Madrid

29609

Hôpital Morvan, Brest

31008

Complejo Hospitalario de Navarra, Pamplona

31059

Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O), Toulouse

34295

Hopital Saint Eloi, Montpellier

35033

CHU de Rennes - Hopital de Pontchaillo, Rennes

35128

Azienda Ospedaliera Di Padova, Padua

37007

Hospital Clinico Universitario de Salamanca, Salamanca

37044

CHU Tours - Hôpital Bretonneau, Tours

44093

CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation, Nantes

44803

Samodzielny Publiczny Szpital Kliniczny nr 1, Zabrze

48202

Henry Ford Health System, Detroit

50134

Azienda Ospedaliera Universitaria Careggi, Florence

54511

Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy

59037

Hopital Claude Huriez - CHU Lille, Lille

60126

Azienda Ospedaliero Universitaria Ospedali Riuniti, Torrette Di Ancona

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70124

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari, Bari

72076

Universitätsklinikum Tübingen, Tübingen

75019

Hopital Robert Debre, Paris

76038

Centre Henri Becquerel, Rouen

79106

Universitaetsklinikum Freiburg, Freiburg im Breisgau

84112

Huntsman Cancer Institute; University of Utah, Salt Lake City

85925

Centre Hospitalier Départemental Les Oudairies, La Roche-sur-Yon

86000

CHU Poitiers - Hopital La Miletrie, Poitiers

115478

"FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow

191024

SRI of Hematology and Transfusiology, Saint Petersburg

197341

North-West Federal Medical Research Center n.a. V.A. Almazov, Saint Petersburg

644013

BHI of Omsk region Clinical Oncology Dispensary, Omsk

650066

Kemerovo Regional Clinical Hospital, Kemerovo

92093-5354

University of California San Diego Medical Center, La Jolla

T2N 2T9

Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience, Calgary

L8N 3Z5

Juravinski Cancer Clinic, Hamilton

H3T 1E2

Jewish General Hospital, Montreal

S7N 4H4

Saskatoon City Hospital;Saskatchewan Cancer Centre, Saskatoon

613 00

Fakultni nemocnice Brno, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

775 20

Fakultní nemocnice Olomouc, Olomouc

708 52

Fakultni nemocnice Ostrava, Ostrava - Poruba

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

128 08

Vseobecna fakultni nemocnice v Praze, Prague

01307

"Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden", Dresden

1081 HV

Amsterdam UMC, Locatie VUMC; Neurology, Amsterdam

1105 AZ

Amsterdam UMC Location AMC, Amsterdam

3318 AT

Albert Schweitzer Ziekenhuis, Dordwijk; Internal Medicine, Hemato-Oncology, Dordrecht

7512 KZ

Medisch Spectrum Twente, Enschede

2333 ZA

Leids Universitair Medisch Centrum; Cardiology, Leiden

3000 CA

Erasmus Medisch Centrum, Rotterdam

Unknown

Middlemore Hospital, Auckland

Uniwersyteckie Centrum Kliniczne, Gdansk

41-500

SP ZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzów

93-513

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz

45-061

Szpital Wojewodzki w Opolu, Opole

02-106

MTZ Clinical Research Sp. z o.o., Warsaw

463-707

Seoul National University Bundang Hospital, Seongnam-si

03722

Severance Hospital, Yonsei University Health System, Seoul

05030

Konkuk University Medical Center, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona; Hematology, Barcelona

221 85

Skånes Universitetssjukhus, Lund

751 85

Akademiska Sjukhuset, Uppsala

BS2 8ED

Bristol Haematology and Oncology centre, Bristol

M20 4BX

The Christie, Manchester

SO16 6YD

Southampton General Hospital, Southampton

SA2 8QA

Singleton Hospital; Pharmacy Department, Swansea

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY