Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab
Study ID: NCT02005471
Conditions
Study Description
Brief Summary: The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego Medical Center, La Jolla, California, United States
Henry Ford Health System, Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center; Clinical Trials Office, New York, New York, United States
Perlmutter Cancer Center NYU Langone Health, New York, New York, United States
Huntsman Cancer Institute; University of Utah, Salt Lake City, Utah, United States
The Canberra Hospital, Garran, Australian Capital Territory, Australia
Concord Repatriation General Hospital, Concord, New South Wales, Australia
St George Hospital, Kogarah, New South Wales, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Royal Hobart Hospital, Hobart, Tasmania, Australia
Frankston Hospital, Frankston, Victoria, Australia
Monash Medical Centre; Haematology, Melbourne, Victoria, Australia
Slade Health Pharmacy, Mount Waverley, Victoria, Australia
Peter MacCallum Cancer Center, North Melbourne, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
The Perth Blood Institute, Nedlands, Western Australia, Australia
Medizinische Universität Innsbruck, Innsbruck, , Austria
LKH - Universitätsklinikum der PMU Salzburg, Salzburg, , Austria
Medizinische Universität Wien, Wien, , Austria
Klinik Ottakring, Wien, , Austria
ZNA Antwerpen; Department Hematology, Antwerpen, , Belgium
Cliniques Universitaires Saint-Luc; Hematology, Bruxelles, , Belgium
AZ Groeninge, Kortrijk, , Belgium
UZ Leuven; Department Hematology, Leuven, , Belgium
CHU UCL Mont-Godinne, Mont-godinne, , Belgium
AZ Delta (Campus Rumbeke), Roeselare, , Belgium
Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience, Calgary, Alberta, Canada
Juravinski Cancer Clinic, Hamilton, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Saskatoon City Hospital;Saskatchewan Cancer Centre, Saskatoon, Saskatchewan, Canada
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Fakultní nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava - Poruba, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Praha, , Czechia
Herlev Hospital, Herlev, , Denmark
Rigshospitalet, København Ø, , Denmark
Odense Universitetshospital, Odense C, , Denmark
Sjællands Universitetshospital, Roskilde, Roskilde, , Denmark
Sygehus Lillebælt, Vejle, Vejle, , Denmark
Hôpital Morvan, Brest, , France
Centre Hospitalier Départemental Les Oudairies, La Roche sur Yon, , France
Hopital Claude Huriez - CHU Lille, Lille, , France
Hopital Saint Eloi, Montpellier, , France
CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation, Nantes, , France
Hopital Robert Debre, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
CHU Poitiers - Hopital La Miletrie, Poitiers, , France
CHU de Rennes - Hopital de Pontchaillo, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O), Toulouse, , France
CHU Tours - Hôpital Bretonneau, Tours, , France
Hôpital de Brabois Adultes, Vandoeuvre-les-nancy, , France
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden, Dresden, , Germany
Universitaetsklinikum Freiburg, Freiburg, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Semmelweis Egyetem, Budapest, , Hungary
Orszagos Onkologiai Intezet, Budapest, , Hungary
Debreceni Egyetem Klinikai Központ; B?rgyógyászati Klinika, Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz, Pecs, , Hungary
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp., Szeged, , Hungary
Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology, Torino, Abruzzo, Italy
Azienda Ospedaliero Universitaria San Martino, Genova, Liguria, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo, Lombardia, Italy
Ospedale San Raffaele, Milano, Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda; SC Farmacia Ospedale, Milano, Lombardia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti, Torrette Di Ancona, Marche, Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari, Bari, Puglia, Italy
Azienda Ospedaliera Universitaria Careggi, Florence, Toscana, Italy
Azienda Ospedaliera Di Padova, Padova, Veneto, Italy
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Konkuk University Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Seoul St. Mary?s Hospital, Seoul, , Korea, Republic of
Amsterdam UMC, Locatie VUMC; Neurology, Amsterdam, , Netherlands
Amsterdam UMC Location AMC, Amsterdam, , Netherlands
Albert Schweitzer Ziekenhuis, Dordwijk; Internal Medicine, Hemato-Oncology, Dordrecht, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
Leids Universitair Medisch Centrum; Cardiology, Leiden, , Netherlands
Erasmus Medisch Centrum, Rotterdam, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
North Shore Hospital; Haematolgy, Auckland, , New Zealand
Middlemore Hospital, Auckland, , New Zealand
Christchurch Hospital NZ, Christchurch, , New Zealand
Baxter Healthcare, Mount Wellington, , New Zealand
SP ZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzow, , Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Lodz, , Poland
Szpital Wojewodzki w Opolu, Opole, , Poland
MTZ Clinical Research Sp. z o.o., Warszawa, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1, Zabrze, , Poland
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin", Moscow, Moskovskaja Oblast, Russian Federation
SRI of Hematology and Transfusiology, Sankt-peterburg, Sankt Petersburg, Russian Federation
North-West Federal Medical Research Center n.a. V.A. Almazov, St. Petersburg, Sankt Petersburg, Russian Federation
Kemerovo Regional Clinical Hospital, Kemerovo, , Russian Federation
BHI of Omsk region Clinical Oncology Dispensary, Omsk, , Russian Federation
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona; Hematology, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Skånes Universitetssjukhus, Lund, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
National Taiwan University Hospital, Taipei, , Taiwan
Bristol Haematology and Oncology centre, Bristol, , United Kingdom
The Christie, Manchester, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Singleton Hospital; Pharmacy Department, Swansea, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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