Spots Global Cancer Trial Database for A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
Official Title: A Multicenter, Open-Label, Single-Arm, Phase IIIb, International Study Evaluating the Safety of Obinutuzumab Alone or in Combination With Chemotherapy in Patients With Previously Untreated or Relapsed/Refractory Chronic Lymphocytic Leukemia
Study ID: NCT01905943
Conditions
Study Description
Brief Summary: This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). This is a Post-Authorization Safety Study. Participants will receive 6 cycles of single-agent obinutuzumab or obinutuzumab in combination with chemotherapy at the investigator's discretion. Each participant will be followed until 30 months after the last participant has been enrolled. Total length of the study is anticipated to be approximately 5 years.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Iturraspe, Santa Fé, , Argentina
Hospital Erasme; Neurologie, Bruxelles, , Belgium
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
CHU Sart-Tilman, Liège, , Belgium
Sint Augustinus Wilrijk, Wilrijk, , Belgium
University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept, Banja Luka, , Bosnia and Herzegovina
University Clinical Center Sarajevo, Clinic for Hematology, Sarajevo, , Bosnia and Herzegovina
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Hospital Amaral Carvalho, Jau, SP, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP, Sao Paulo, SP, Brazil
Hospital Sirio Libanes; Centro de Oncologia, Sao Paulo, SP, Brazil
Hospital Estadual do Servidor Publico; Hematologia, Sao Paulo, SP, Brazil
Hospital das Clinicas - FMUSP; Hematologia, Sao Paulo, SP, Brazil
Hospital Santa Marcelina;Oncologia, Sao Paulo, SP, Brazil
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
Regional health authority A vitalite health network, Moncton, New Brunswick, Canada
Queen Elizabeth II Health Sciences Centre; Oncology, Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials, Barrie, Ontario, Canada
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie, Greenfield Park, Quebec, Canada
Hopital Maisonneuve- Rosemont; Oncology, Montreal, Quebec, Canada
Centre de sante et de services sociaux Rimouski Neigette, Rimouski, Quebec, Canada
Saskatoon Cancer Centre; Uni of Saskatoon Campus, Saskatoon, Saskatchewan, Canada
CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie, Quebec, , Canada
Cairo University Hospital Al Kasr El Ainy, Cairo, , Egypt
National Cancer Institute, Cairo, , Egypt
North Estonia Regional Hospital; Hematology, Tallinn, , Estonia
Tartu Uni Hospital; Hematology - Oncology Clinic, Tartu, , Estonia
Kuopio University Hospital, Kuopio, , Finland
Tampere University Hospital; Hematology, Tampere, , Finland
Turku Uni Central Hospital; Dept of Internal Medicine, Turku, , Finland
Hotel Dieu; Medecine D, Angers, , France
Ch Victor Dupouy; Hematologie, Argenteuil, , France
Hopital Augustin Morvan; Hematologie, Brest, , France
Hopital Cote De Nacre; Hematologie Biologique, Caen, , France
Chu Estaing; Hematologie Clinique Adultes, Clermont Ferrand, , France
Hopital Henri Mondor; Hematologie Clinique, Creteil, , France
Chu Site Du Bocage;Hematologie Clinique, Dijon, , France
Centre Hospitalier Departemental Les Oudairies, La Roche Sur Yon, , France
Ch Du Mans; Medecine Hematologie Oncologie, Le Mans, , France
Hopital Claude Huriez; Hematologie, Lille, , France
Hopital Uni Ire Dupuytren; Hematologie, Limoges, , France
Hopital Saint Eloi; Hematologie Oncologie Medicale, Montpellier, , France
Hopital Emile Muller; Hematologie, Mulhouse, , France
Hopital Hotel Dieu Et Hme;Hopital De Jour, Nantes, , France
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset), Paris, , France
Hopital Saint Antoine; Hematologie Clinique, Paris, , France
Hopital Pitie Salpetriere; Hematologie Clinique, Paris, , France
Hopital Saint Jean; Hematologie, Perpignan, , France
Hopital De Haut Leveque; Hematologie Clinique, Pessac, , France
Ch Lyon Sud; Hemato Secteur Jules Courmont, Pierre Benite, , France
Centre Hospitalier René Dubos; Hematologie, Pontoise, , France
Hopital Robert Debre; Hematologie Clinique, Reims, , France
Centre Henri Becquerel; Hematologie, Rouen, , France
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll, St Brieuc, , France
Hopital Bretonneau; Hematologie Therapie Cellulaire, Tours, , France
Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter, Augsburg, , Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie, Dresden, , Germany
Gemeinschaftspraxis; Prof. Dr. Michael Kiehl und Dr.med. Wolfgang Stein, Frankfurt an der Oder, , Germany
Onkologisches Zentrum am Bethanien-Kankenhaus, Frankfurt, , Germany
Dres.Andreas Ammon und Dirk Meyer, Göttingen, , Germany
OncoResearch Lerchenfeld GmbH, Hamburg, , Germany
Onkologische Schwerpunktpraxis Lübeck, Lübeck, , Germany
Onkologische Gemeinschaftspraxis, Magdeburg, , Germany
Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin, Mutlangen, , Germany
Dres. Hans-Dieter Schick Dorothea Schick Burkhard Schmidt u.w., München, , Germany
Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura, Neunkirchen/Saar, , Germany
eps - early phase GmbH, Pößneck, , Germany
Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie, Recklinghausen, , Germany
Schwerpunktpraxis & Tagesklinik f. Hämatologie & Onkologie Regensdorf / Schwandorf / Wörth, Regensburg, , Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo., Ulm, , Germany
Onkologische Schwerpunktpraxis Dres. Rudolf Schlag und Björn Schöttker, Würzburg, , Germany
General Hospital of Athens Evangelismos; Hematology, Athens, , Greece
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine, Athens, , Greece
Laiko General Hospital; Hematology Clinic, Athens, , Greece
University Hospital of Ioannina; Hematology, Ioannina, , Greece
Georgios Papanikolaou Hospital; Hematology Department, Thessaloniki, , Greece
Mater Misericordiae Uni Hospital; Oncology, Dublin, , Ireland
University Hospital Limerick - Oncology, Limerick, , Ireland
Waterford Regional Hospital; Department Of Medical Oncology, Waterford, , Ireland
Soroka Medical Center; Hematology Deptartment, Beer Sheva, , Israel
Bnei-Zion Medical Center; Hematology Dept, Haifa, , Israel
Hadassah Ein Karem Hospital; Haematology, Jerusalem, , Israel
Kaplan Medical Center, Rehovot, , Israel
Ichilov Sourasky Medical Center; Heamatology, Tel Aviv, , Israel
Az. Osp. Pugliese; Divisione de Ematologia, Catanzaro, Calabria, Italy
Ospedale Cardarelli; Divisione Di Ematologia, Napoli, Campania, Italy
Arcispedale S. Anna; Sezione Di Ematologia, Ferrara, Emilia-Romagna, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia, Modena, Emilia-Romagna, Italy
AUSL di Piacenza - Ospedale "Guglielmo da Saliceto";U.O. Ematologia, Piacenza, Emilia-Romagna, Italy
Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia, Ravenna, Emilia-Romagna, Italy
Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia, Rimini, Emilia-Romagna, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol, Roma, Lazio, Italy
Uni Degli Studi Di Genova; 1A Divisione Di Ematologia, Genova, Liguria, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora, Milano, Lombardia, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia, Milano, Lombardia, Italy
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad, Novara, Piemonte, Italy
Ospedale Molinette - Universita' Di Torino; Cliniche Universitarie Ematologia I, Torino, Piemonte, Italy
Azienda ospedaliera oo rr di foggi; Hematology, Foggia, Puglia, Italy
Ospedale Vito Fazzi; Div. Oncoematologia, Lecce, Puglia, Italy
Ospedale Oncologico A Businco-Cagliari; Ematologia Sez., Cagliari, Sardegna, Italy
Azienda USL 6 Livorno - P.O. Livorno; U.O. Ematologia Clinica, Livorno, Toscana, Italy
Pusan University Hospital, Busan, , Korea, Republic of
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul, , Korea, Republic of
Samsung Medical Centre; Division of Hematology/Oncology, Seoul, , Korea, Republic of
RECUH, Oncology Centre of Latvia; Clinic of Chemotherapy and Heamatology, Riga, , Latvia
Hospital of Lithuanian University of Health. Sciences Kaunas Clinics, Kaunas, , Lithuania
Vilnius University Hospital Santariskiu Clinic, Hematology, Oncology and Tranfusion Medicine Center, Vilnius, , Lithuania
Hospital General De Culiacan; Servicio De Hematologia, Culiacan, , Mexico
Hospital General de México; Haematology, Mexico City, , Mexico
Centro Medico Nacional Sxxi - Imss; Haematology, Mexico City, , Mexico
Hospital Universitario Dr. Jose E. Gonzalez; Haematology, Monterrey, , Mexico
Centro de Estudios Clinicos de Queretaro (CECLIQ), Queretaro, , Mexico
University Clinic of Hematology Skopje, Hospital Care Department, Skopje, , North Macedonia
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie, Lublin, , Poland
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, , Poland
Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej, Opole, , Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny, Slupsk, , Poland
Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula, Lisboa, , Portugal
IPO do Porto; Servico de Onco-Hematologia, Porto, , Portugal
Policlinica de Diagnostic Rapid, Brasov, , Romania
Spitalul Clinic Judetean de Urgenta Brasov; Clinica de Hematologie, Brasov, , Romania
Spitalul Clinic Coltea; Clinica de Hematologie, Bucuresti, , Romania
Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie, Timisoara, , Romania
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF, Moscow, , Russian Federation
Vladimirskiy Regional Scientific Research Inst. ; Hematology, Moscow, , Russian Federation
Almazov Federal Heart, Blood and Endocrinilogy Centre; Hematology department, Saint-Petersburg, , Russian Federation
Regional Oncology Center, Volgograd, , Russian Federation
Institute of Hematology, Belgrade, , Serbia
Fakultna Nemocnica Roosevelta; Dept. of Haematology, Banska Bystrica, , Slovakia
National Oncology Inst. ; Dept. of Haematology, Bratislava, , Slovakia
Hospital Celje; Haematology Dept, Celje, , Slovenia
Clinical Center Ljubljana; Haematology Dept, Ljubljana, , Slovenia
Hospital Maribor; Haematology Dept, Maribor, , Slovenia
Hospital De Txagorritxu; Servicio de Hematologia, Vitoria, Alava, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia, Badalona, Barcelona, Spain
Hospital Universitario Son Espases, Palma De Mallorca, Islas Baleares, Spain
Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia, Logroño, LA Rioja, Spain
Hospital Quiron de Madrid; Servicio de Hematologia, Pozuelo de Alarcon, Madrid, Spain
Hospital San Pedro De Alcantara; Servicio de Hematologia, Caceres, , Spain
Hospital Universitario Reina Sofia; Servicio de Hematologia, Cordoba, , Spain
Hospital Infanta Leonor; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Hematología, Madrid, , Spain
Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia, Orense, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Sevilla, , Spain
Hospital Universitario la Fe; Servicio de Hematologia, Valencia, , Spain
Universitetssjukhuset i Linköping, Hematologkliniken, Linkoeping, , Sweden
Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders, Malmö, , Sweden
Uddevalla Sjukhus; Medicinkliniken, Uddevalla, , Sweden
Akademiska Sjukhuset, Uppsala, , Sweden
Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin, Aarau, , Switzerland
Universitätsspital Basel; Hämatologie, Basel, , Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI), Bellinzona, , Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie, Chur, , Switzerland
HUG; Hématologie, Geneve, , Switzerland
Luzerner Kantonsspital, Hämatologie, Luzern, , Switzerland
OnkoZentrum Zuerich, Zürich, , Switzerland
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine, Bangkok, , Thailand
Ramathibodi Hospital; Division of Hematology, Department of Medicine, Bangkok, , Thailand
Siriraj Hospital; Division of Hematology, Department of Medicine, Bangkok, , Thailand
Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine, Chiang Mai, , Thailand
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine, Khon Kaen, , Thailand
Cukurova Uni ; Hematology, Adana, , Turkey
Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi, Ankara, , Turkey
Ankara University; Hematology, Ankara, , Turkey
Pamukkale Uni. Med. Fac., Denizli, , Turkey
Gaziantep University Medical School; Hematology, Gaziantep, , Turkey
Istanbul Uni Capa Hospital; Hematology, Istanbul, , Turkey
Dokuz Eylul Uni ; Hematology, Izmir, , Turkey
Erciyes Uni ; Hematology, Kayseri, , Turkey
Ondokuzmayis University Medical Faculty Heamatology Department, Samsun, , Turkey
Karadeniz Technical Uni School of Medicine; Hematology, Trabzon, , Turkey
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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