Spots Global Cancer Trial Database for Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia
Official Title: A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions
Study ID: NCT02242942
Conditions
Study Description
Brief Summary: This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
San Diego Pacific Hematology Assocates, Encinitas, California, United States
UC San Diego Health System, La Jolla, California, United States
Banner MD Anderson Cancer Center, Greeley, Colorado, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Henry Ford Hospital, Detroit, Michigan, United States
Joe Arrington Cancer Center, Lubbock, Texas, United States
Hospital Italiano, Buenos Aires, , Argentina
Liverpool Hospital, Liverpool, New South Wales, Australia
Tweed Hospital, Tweed Heads, New South Wales, Australia
The Townsville Hospital, Douglas, Queensland, Australia
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital; Haematology Clinical Trials, Adelaide, South Australia, Australia
Ashford Cancer Centre Research; Internal Medicine/Medical Oncology, Ashford, South Australia, Australia
Box Hill Hospital, Box Hill, Victoria, Australia
The Northern Hospital, Epping, Victoria, Australia
Monash Medical Centre; Haematology, Melbourne, Victoria, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie, Innsbruck, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie, Wien, , Austria
Hanusch-Krankenhaus; Iii. Medizinische Abt., Wien, , Austria
Wilhelminenspital; I. Medizinische Abt., Wien, , Austria
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP, Sao Paulo, SP, Brazil
Hospital Sírio-Libanês, Sao Paulo, SP, Brazil
Hospital das Clinicas - FMUSP, Sao Paulo, SP, Brazil
Hospital Santa Marcelina, Sao Paulo, SP, Brazil
UMHAT Dr Georgi Stranski; Hematology, Pleven, , Bulgaria
UMHAT " Sveti Georgi" Plovdiv - Clinic of Oncology and Hematology, Plovdiv, , Bulgaria
University Hospital Sv.Georgi Clnic of Hematology; Hematology, Plovdiv, , Bulgaria
University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology, Sofia, , Bulgaria
MHAT Hristo Botev; First Internal Department, Vratsa, , Bulgaria
Tom Baker Cancer Centre; Dept of Medicine, Calgary, Alberta, Canada
Queen Elizabeth II Health Sciences Centre; Oncology, Halifax, Nova Scotia, Canada
Jewish General Hospital, Montreal, Quebec, Canada
University Hospital Center Zagreb; Haematology Department, Zagreb, , Croatia
University Hospital Merkur Clinic for Internal Medicine/ Hematology, Zagreb, , Croatia
Herlev Hospital, Herlev, , Denmark
Rigshospitalet, København Ø, , Denmark
Sjaellands Universitetshospital, Roskilde, Roskilde, , Denmark
Sygehus Lillebælt, Vejle, Vejle, , Denmark
North Estonia medical Centre; Hematology, Tallinn, , Estonia
Tartu Uni Hospital; Hematology - Oncology Clinic, Tartu, , Estonia
CHU Besançon - Hôpital Jean Minjoz, Besançon Cedex, , France
Institut d'Hématologie de Basse Normandie, Caen, , France
Chu Estaing; Hematologie Clinique Adultes, Clermont Ferrand, , France
Hopital Henri Mondor, Creteil, , France
CHU de Dijon - Hopital le Bocage, Dijon, , France
CHU de Grenoble, Grenoble, , France
Centre Jean Bernard, Le Mans, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Hôpital Saint Eloi; Service d?Hématologie et Oncologie Clinique - Recherche Clinique, Montpellier, , 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 Pontchaillou; Hematologie Clinique, Rennes, , France
Centre Henri Becquerel; Hematologie, Rouen, , France
CH de Toulon Hôpital Sainte Musse, Toulon, , France
Institut Gustave Roussy - Hematologie, Villejuif, , France
Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm., Aachen, , Germany
Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie, Amberg, , Germany
Charite - Universitätsmedizin Berlin, Berlin, , Germany
Charite - Campus Virchow-Klinikum, Berlin, , Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie, Dresden, , Germany
Uniklinikum "Carl Gustav Carus"; Med. Klinik 1; Hämatologie, Zelltherapie und Medizinische Onkologie, Dresden, , Germany
Universitätsklinikum Essen; Klinik für Hämatologie, Essen, , Germany
Klinik Esslingen; Klinik für Allgemeine Innere Medizin, Onkologie/Haematologie, Esslingen, , Germany
Klinikum Frankfurt/Oder, Frankfurt/Oder, , Germany
Uniklinikum Freiburg, Freiburg, , Germany
Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie, Göttingen, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte, Herne, , Germany
Praxisklinik für Hämatologie und Onkologie Koblenz, Koblenz, , Germany
Universitätsklinikum Köln; Innere Medizin I; Onkologie, Hämatologie, Köln, , Germany
Tagesklinik Landshut; Hämatologie/Onkologie, Landshut, , Germany
Klinikum rechts der Isar der Technischen Universität München, Munchen, , Germany
Klinikum Schwäbisch Gmünd, Mutlangen, , Germany
Kliniken Maria Hilf GmbH Innere Medizin I, Mönchengladbach, , Germany
München Klinik Schwabing; Klinik für Hämatologie, Onkologie, Immunologie, München, , Germany
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III, München, , Germany
Gemeinschaftspraxis Dr. med. Holger Klaproth, Neunkirchen/Saar, , Germany
Brüderkrankenhaus St. Josef Paderborn, Paderborn, , Germany
Krankenhaus Barmherzige Bruder Regensburg, Regensburg, , Germany
Marienhospital, Stuttgart, , Germany
Robert-Bosch-Krankenhaus, Stuttgart, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universtitätsklinikum Ulm; Klinik für Innere Medizin III, Ulm, , Germany
Medizinisches Versorgungszentrum Nuklearmedizin-Strahlentherapie-Onkologie, Weiden, , Germany
Arcispedale S. Anna; Sezione Di Ematologia, Ferrara, Emilia-Romagna, Italy
Ospedali Riuniti Papardo-Piemonte; Struttura Complessa Di Ematologia, Messina, Lazio, Italy
Uni Cattolica; Divisione Di Ematologia, Roma, Lazio, Italy
AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette, Torino, Lazio, Italy
Ospedale San Raffaele, Milano, Lombardia, Italy
Az. Osp. S. Maria; Dept. Di Oncologia Medica, Terni, Umbria, Italy
Ospedale dell' Angelo; U.O. Ematologia, Venezia Mestre, Veneto, Italy
Hospital General de Culiacan, Culiacan, Sinaloa, Mexico
Canterbury Health Laboratories; Haematology, Christchurch, , New Zealand
Dunedin Hospital, Dunedin, , New Zealand
Midcentral District Health Board, Palmerston North, , New Zealand
Wellington Hospital, Wellington, , New Zealand
Uniwersytecki Szpital Kliniczny w Bia?ymstoku, Klinika Hematologii z Pododdzia?em Chorob Naczyn, Bialystok, , Poland
Samodzielny Public Zaklad, Chorzów, , Poland
Wojewódzki Szpital Specjalistyczny im.Miko?ajaKopernika;KlinikaHematologiiUniwersytetuMedycznego, Lodz, , Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddzia? Chorób Wewnetrznych/Hematologiczny, Slupsk, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroc?awiu; Klinika Hematologii, Wroclaw, , Poland
Fundeni Clinical Inst. ; Hematology Dept, Bucharest, , Romania
Institutul Regional de Oncologie Iasi; Clinica de Hematologie, Iasi, , Romania
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie, Targu-mures, , Romania
SBEI of HPE ?Bashkir State Medical University? of MoH RF, UFA, Baskortostan, Russian Federation
Moscow State Budgetary Healthcare Institution, Moscow, Moskovskaja Oblast, Russian Federation
Regional Clinical Hospital N.A. Semashko; Hematology, Nizhny Novgorod, Niznij Novgorod, Russian Federation
Rostov State Medical Uni ; Hematology, Rostov-na-donu, Rostov, Russian Federation
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan, Kazan, Tatarstan, Russian Federation
Penza Regional Oncology Dispensary, Penza, , Russian Federation
Clinical MSCh No1, Perm, , Russian Federation
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
Hospital Universitario de Canarias;servicio de Hematologia, La Laguna, Tenerife, Spain
Hospital del Mar; Servicio de Hematologia, Barcelona, , Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona, , Spain
Hospital Universitario de la Princesa; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid, , Spain
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia, Salamanca, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología, Toledo, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia, Valencia, , Spain
Inselspital Bern; Hämatologie und Hämatologisches Zentrallabor, Bern, , Switzerland
Luzerner Kantonsspital, Hämatologie, Luzern, , Switzerland
Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie, Zürich, , Switzerland
Birmingham Heartlands Hospital, Birmingham, , United Kingdom
Boston Pilgrim Hospital, Boston,Lincolnshire, , United Kingdom
Western General Hospital; Department of Haematology, Edinburgh, , United Kingdom
Lincoln County Hospital, Lincoln, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southhampton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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