979
Participants
Start Date
November 4, 2013
Primary Completion Date
December 29, 2016
Study Completion Date
October 8, 2018
Bendamustine
Bendamustine: 90 milligram per millilitre square (mg/m\^2) IV over 60 minutes once daily (QD) Day 1-2 in participants previously untreated or 70 mg/m\^2 I.V. over 60 minutes QD Day 1-2 in participants with relapsed/refractory disease. In non-fit participants only, investigators may opt at their own discretion to use lower initial doses of bendamustine, i.e., bendamustine 70 mg/m\^2 in previously untreated participants, and bendamustine 50 mg/m\^2 in relapsed/refractory subjects (over 60 minutes qd Day 1-2 for each administration).
Chlorambucil
Chlorambucil 0.5 mg/kg p.o. qd on Day 1 and Day 15 in non-fit participants only.
Cyclophosphamide
Cyclophosphamide 250 mg/m\^2 I.V. over 15-30 minutes qd Day 1-3 or Cyclophosphamide 250 mg/m\^2 p.o. QD Day 1-3 in fit participants only.
Fludarabine
Fludarabine 25 mg/m\^2 I.V. over 30 minutes QD Day 1-3 or Fludarabine 40 mg/m\^2 per os (p.o.) QD Day 1-3 in fit participants only.
Obinutuzumab
Participants will receive obinutuzumab 1000 mg IV infusion on Days 1/2 (dose split over 2 consecutive days; 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1, and on Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle is of 28-days duration.
Mater Misericordiae Uni Hospital; Oncology, Dublin
University Clinic of Hematology Skopje, Hospital Care Department, Skopje
Hospital Erasme; Neurologie, Brussels
RECUH, Oncology Centre of Latvia; Clinic of Chemotherapy and Heamatology, Riga
Cliniques Universitaires St-Luc, Brussels
HUG; Hématologie, Geneva
Clinical Center Ljubljana; Haematology Dept, Ljubljana
Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula, Lisbon
Hospital Maribor; Haematology Dept, Maribor
Sint Augustinus Wilrijk, Wilrijk
Hospital Iturraspe, Santa Fé
Hospital Celje; Haematology Dept, Celje
Jessa Zkh (Campus Virga Jesse), Hasselt
CHU Sart-Tilman, Liège
Universitätsspital Basel; Hämatologie, Basel
Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin, Aarau
Luzerner Kantonsspital, Hämatologie, Lucerne
Istituto Oncologico della Svizzera Italiana (IOSI), Bellinzona
Kantonsspital Graubünden;Onkologie und Hämatologie, Chur
OnkoZentrum Zuerich, Zurich
Hospital San Pedro De Alcantara; Servicio de Hematologia, Cáceres
Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I, Turin
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine, Bangkok
Ramathibodi Hospital; Division of Hematology, Department of Medicine, Bangkok
Siriraj Hospital; Division of Hematology, Department of Medicine, Bangkok
Institute of Hematology, Belgrade
Centro Medico Nacional Sxxi - Imss; Haematology, Mexico City
Cairo University Hospital Al Kasr El Ainy, Cairo
National Cancer Institute, Cairo
North Estonia Regional Hospital; Hematology, Tallinn
Hospital Universitario Reina Sofia; Servicio de Hematologia, Córdoba
Hopital Cote De Nacre; Hematologie Biologique, Caen
Gemeinschaftspraxis; Prof. Dr. Michael Kiehl und Dr.med. Wolfgang Stein, Frankfurt (Oder)
Uni Degli Studi Di Genova; 1A Divisione Di Ematologia, Genoa
Pamukkale Uni. Med. Fac., Denizli
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora, Milan
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia, Milan
Turku Uni Central Hospital; Dept of Internal Medicine, Turku
Chu Site Du Bocage;Hematologie Clinique, Dijon
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll, Saint-Brieuc
OncoResearch Lerchenfeld GmbH, Hamburg
Onkologische Schwerpunktpraxis Lübeck, Lübeck
Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia, Logroño
Gaziantep University Medical School; Hematology, Gaziantep
Hospital Infanta Leonor; Servicio de Hematologia, Madrid
Hospital Universitario Clínico San Carlos; Servicio de Hematología, Madrid
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad, Novara
Hospital Quiron de Madrid; Servicio de Hematologia, Pozuelo de Alarcón
"AUSL di Piacenza - Ospedale Guglielmo da Saliceto;U.O. Ematologia", Piacenza
Hopital Augustin Morvan; Hematologie, Brest
Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia, Ourense
Tampere University Hospital; Hematology, Tampere
Hopital De Haut Leveque; Hematologie Clinique, Pessac
Hopital Saint Eloi; Hematologie Oncologie Medicale, Montpellier
Istanbul Uni Capa Hospital; Hematology, Istanbul
Dokuz Eylul Uni ; Hematology, Izmir
Hopital Bretonneau; Hematologie Therapie Cellulaire, Tours
Dres.Andreas Ammon und Dirk Meyer, Göttingen
Erciyes Uni ; Hematology, Kayseri
Onkologische Gemeinschaftspraxis, Magdeburg
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine, Khon Kaen
Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Seville
A.O. Universitaria Policlinico Di Modena; Ematologia, Modena
Hopital Hotel Dieu Et Hme;Hopital De Jour, Nantes
Arcispedale S. Anna; Sezione Di Ematologia, Ferrara
Uddevalla Sjukhus; Medicinkliniken, Uddevalla
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie, Recklinghausen
Hospital Universitario la Fe; Servicio de Hematologia, Valencia
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola
Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia, Rimini
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia, Ravenna
Hotel Dieu; Medecine D, Angers
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics, Kaunas
Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine, Chiang Mai
Tartu Uni Hospital; Hematology - Oncology Clinic, Tartu
Hopital Robert Debre; Hematologie Clinique, Reims
Ondokuzmayis University Medical Faculty Heamatology Department, Samsun
Azienda USL 6 Livorno - P.O. Livorno; U.O. Ematologia Clinica, Livorno
Hopital Claude Huriez; Hematologie, Lille
Onkologisches Zentrum am Bethanien-Kankenhaus, Frankfurt
Karadeniz Technical Uni School of Medicine; Hematology, Trabzon
Chu Estaing; Hematologie Clinique Adultes, Clermont-Ferrand
Hospital Universitario Dr. Jose E. Gonzalez; Haematology, Monterrey
Hopital Saint Jean; Hematologie, Perpignan
Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura, Neunkirchen/Saar
Hopital Emile Muller; Hematologie, Mulhouse
Ch Lyon Sud; Hemato Secteur Jules Courmont, Pierre-Bénite
Kuopio University Hospital, Kuopio
University Clinical Center Sarajevo, Clinic for Hematology, Sarajevo
Azienda ospedaliera oo rr di foggi; Hematology, Foggia
Ch Du Mans; Medecine Hematologie Oncologie, Le Mans
Ospedale Vito Fazzi; Div. Oncoematologia, Lecce
Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin, Mutlangen
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset), Paris
Hopital Saint Antoine; Hematologie Clinique, Paris
Hopital Pitie Salpetriere; Hematologie Clinique, Paris
Centro de Estudios Clinicos de Queretaro (CECLIQ), Querétaro
Centre Henri Becquerel; Hematologie, Rouen
Ospedale Cardarelli; Divisione Di Ematologia, Napoli
Hospital General De Culiacan; Servicio De Hematologia, Culiacán
Dres. Hans-Dieter Schick Dorothea Schick Burkhard Schmidt u.w., München
Centre Hospitalier Departemental Les Oudairies, La Roche-sur-Yon
Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter, Augsburg
Hopital Uni Ire Dupuytren; Hematologie, Limoges
University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept, Banja Luka
Az. Osp. Pugliese; Divisione de Ematologia, Catanzaro
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo., Ulm
Schwerpunktpraxis & Tagesklinik f. Hämatologie & Onkologie Regensdorf / Schwandorf / Wörth, Regensburg
Hopital Henri Mondor; Hematologie Clinique, Créteil
Ch Victor Dupouy; Hematologie, Argenteuil
Centre Hospitalier René Dubos; Hematologie, Pontoise
Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker, Würzburg
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF, Moscow
Vladimirskiy Regional Scientific Research Inst. ; Hematology, Moscow
Almazov Federal Heart, Blood and Endocrinilogy Centre; Hematology department, Saint Petersburg
Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie, Timișoara
Regional Oncology Center, Volgograd
Policlinica de Diagnostic Rapid, Brasov
Spitalul Clinic Judetean de Urgenta Brasov; Clinica de Hematologie, Brasov
Bnei-Zion Medical Center; Hematology Dept, Haifa
Ichilov Sourasky Medical Center; Heamatology, Tel Aviv
Kaplan Medical Center, Rehovot
Soroka Medical Center; Hematology Deptartment, Beersheba
Hadassah Ein Karem Hospital; Haematology, Jerusalem
Hospital das Clinicas - UFRGS, Porto Alegre
Hospital de Cancer de Barretos, Barretos
Hospital Amaral Carvalho, Jaú
Instituto de Ensino e Pesquisa Sao Lucas - IEP, São Paulo
Hospital Sirio Libanes; Centro de Oncologia, São Paulo
Hospital Estadual do Servidor Publico; Hematologia, São Paulo
Hospital das Clinicas - FMUSP; Hematologia, São Paulo
Hospital Santa Marcelina;Oncologia, São Paulo
Cancer Care Manitoba, Winnipeg
Regional health authority A vitalite health network, Moncton
Queen Elizabeth II Health Sciences Centre; Oncology, Halifax
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials, Barrie
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie, Greenfield Park
Hopital Maisonneuve- Rosemont; Oncology, Montreal
Centre de sante et de services sociaux Rimouski Neigette, Rimouski
Saskatoon Cancer Centre; Uni of Saskatoon Campus, Saskatoon
CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie, Québec
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie, Dresden
eps - early phase GmbH, Pößneck
General Hospital of Athens Evangelismos; Hematology, Athens
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine, Athens
Laiko General Hospital; Hematology Clinic, Athens
University Hospital of Ioannina; Hematology, Ioannina
Georgios Papanikolaou Hospital; Hematology Department, Thessaloniki
University Hospital Limerick - Oncology, Limerick
Waterford Regional Hospital; Department Of Medical Oncology, Waterford
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol, Rome
Ospedale Oncologico A Businco-Cagliari; Ematologia Sez., Cagliari
Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center, Vilnius
Hospital General de México; Haematology, Mexico City
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie, Lublin
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn
Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej, Opole
Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny, Słupsk
IPO do Porto; Servico de Onco-Hematologia, Porto
Spitalul Clinic Coltea; Clinica de Hematologie, Bucharest
Fakultna Nemocnica Roosevelta; Dept. of Haematology, Banská Bystrica
National Oncology Inst. ; Dept. of Haematology, Bratislava
Pusan University Hospital, Busan
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul
Samsung Medical Centre; Division of Hematology/Oncology, Seoul
Hospital De Txagorritxu; Servicio de Hematologia, Vitoria-Gasteiz
Hospital Universitario Son Espases, Palma de Mallorca
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia, Badalona
Universitetssjukhuset i Linköping, Hematologkliniken, Linköping
Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders, Malmo
Akademiska Sjukhuset, Uppsala
Cukurova Uni ; Hematology, Adana
Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi, Ankara
Ankara University; Hematology, Ankara
Hoffmann-La Roche
INDUSTRY