CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
Launched by HOFFMANN-LA ROCHE · Jan 31, 2014
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
Protocol BO21004 is divided into 3 separate Unique Protocol IDs for reporting results on clinicaltrials.gov because there are 3 separate primary analyses conducted at different time-points.
* BO21004 (Stage 1a) \[NCT01010061\] includes the analysis of 2 of the 3 arms obinutuzumab plus chlorambucil (Glb) compared to chlorambucil (Clb) reported separately.
* BO21004 (Stage 1b) \[NCT01998880\] includes the analysis of 2 of the 3 arms rituximab plus chlorambucil (RClb) compared to chlorambucil (Clb) reported separately.
* BO21004 (Stage 2) includes the analysis of 2 of the 3 arms obinutuzumab ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults \>/=18 years
- • Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic Lymphoma (B-CLL)
- • Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according to the National Cancer Institute (NCI) criteria
- • Total Cumulative Illness Rating Scale (CIRS) \> 6 and/or creatinine clearance \< 70 ml/min.
- Exclusion Criteria:
- • Prior CLL therapy
- • Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
- • History of other malignancy unless the malignancy has been in remission without treatment for \>/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone
- • Positive hepatitis serology (HBV, HCV) or positive HIV or Human T-Cell Leukemia Virus (HTLV) testing
- • Patients with active infection requiring systemic treatment.
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Innsbruck, , Austria
Wien, , Austria
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Freiburg, , Germany
Oldenburg, , Germany
Ravensburg, , Germany
Villingen Schwenningen, , Germany
Jaen, , Spain
Madrid, , Spain
Basel, , Switzerland
Bern, , Switzerland
Zürich, , Switzerland
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
Leicester, , United Kingdom
Chicago, Illinois, United States
Edmonton, Alberta, Canada
Frankfurt, , Germany
Trier, , Germany
Hong Kong, , Hong Kong
Kazan, , Russian Federation
Valencia, , Spain
Baltimore, Maryland, United States
London, , United Kingdom
Baltimore, Maryland, United States
Montreal, Quebec, Canada
San Diego, California, United States
Halifax, Nova Scotia, Canada
Pierre Benite, , France
Berlin, , Germany
Gosford, New South Wales, Australia
Southport, Queensland, Australia
Barcelona, , Spain
Zaragoza, , Spain
Aalborg, , Denmark
Vejle, , Denmark
århus, , Denmark
Monterrey, , Mexico
Malaga, , Spain
Muenchen, , Germany
Bangkok, , Thailand
Hamburg, , Germany
Praha 2, , Czechia
Eschweiler, , Germany
Essen, , Germany
Kiel, , Germany
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Creteil, , France
København, , Denmark
Odense, , Denmark
Bobigny, , France
Lyon, , France
Paris, , France
Mainz, , Germany
Khon Kaen, , Thailand
Nottingham, , United Kingdom
Sutton, , United Kingdom
Zagreb, , Croatia
Pessac, , France
Tübingen, , Germany
Liverpool, New South Wales, Australia
Marseille, , France
Toulouse, , France
La Coruna, , Spain
Poitiers, , France
Tours, , France
Kaiserslautern, , Germany
Santiago De Compostela, , Spain
Rennes, , France
Graz, , Austria
Montpellier, , France
Aarau, , Switzerland
Angers, , France
Lille, , France
Nantes, , France
Barrie, Ontario, Canada
Heidelberg, , Germany
Wuerzburg, , Germany
Sevilla, , Spain
Rosario, , Argentina
Kogarah, New South Wales, Australia
Clermont Ferrand, , France
St. Gallen, , Switzerland
Ulm, , Germany
Salamanca, , Spain
Varna, , Bulgaria
Köln, , Germany
Enschede, , Netherlands
München, , Germany
Tartu, , Estonia
Woolloongabba, Queensland, Australia
Giessen, , Germany
Roma, Lazio, Italy
Karlsruhe, , Germany
Reims, , France
Oviedo, Asturias, Spain
Rouen, , France
Cardiff, , United Kingdom
Rimouski, Quebec, Canada
Sao Paulo, Sp, Brazil
Erlangen, , Germany
Frankston, Victoria, Australia
Christchurch, , New Zealand
St. Leonards, New South Wales, Australia
Mannheim, , Germany
Frankfurt An Der Oder, , Germany
Greifswald, , Germany
Rostock, , Germany
Vandoeuvre Les Nancy, , France
Bucharest, , Romania
Tallinn, , Estonia
Caen, , France
Adelaide, New South Wales, Australia
Ansbach, , Germany
Frankfurt Am Main, , Germany
Lemgo, , Germany
Modena, Emilia Romagna, Italy
Chur, , Switzerland
Bournemouth, , United Kingdom
Buenos Aires, , Argentina
Detmold, , Germany
Porta Westfalica, , Germany
Weilheim, , Germany
Genova, Liguria, Italy
Sabadell, Barcelona, Spain
Pamplona, Navarra, Spain
La Laguna, Tenerife, Spain
Melbourne, Victoria, Australia
Murcia, , Spain
Toledo, , Spain
Göttingen, , Germany
Lüdenscheid, , Germany
Stuttgart, , Germany
Ferrara, Emilia Romagna, Italy
Sydney, New South Wales, Australia
Luzern, , Switzerland
Duisburg, , Germany
Saarbruecken, , Germany
Delftzijl, , Netherlands
Cairo, , Egypt
Bonn, , Germany
Leer, , Germany
Milano, Lombardia, Italy
Cagliari, Sardegna, Italy
Santander, Cantabria, Spain
Jerez De La Frontera, Cadiz, Spain
Santiago De Compostela, La Coruña, Spain
La Coruna, La Coruña, Spain
Leeuwarden, , Netherlands
Nizhny Novgorod, , Russian Federation
Ufa, , Russian Federation
Le Mans, , France
Hannover, , Germany
Recklinghausen, , Germany
Witten, , Germany
Cambridge, , United Kingdom
London, , United Kingdom
Auckland, , New Zealand
Lörrach, , Germany
Worms, , Germany
Torino, Piemonte, Italy
Bremen, , Germany
Goiania, Go, Brazil
Sofia, , Bulgaria
Santo Andre, Sp, Brazil
Esslingen, , Germany
Orbassano, Piemonte, Italy
Hradec Kralove, , Czechia
Nieuwegein, , Netherlands
Vratsa, , Bulgaria
Koblenz, , Germany
Dresden, , Germany
Frechen, , Germany
Kronach, , Germany
Magedburg, , Germany
Mutlangen, , Germany
Neunkirchen/Saar, , Germany
Regensburg, , Germany
Aguascalientes, , Mexico
Bratislava, , Slovakia
Greenslopes, Queensland, Australia
Kurralta Park, South Australia, Australia
Würzburg, , Germany
Manresa, Barcelona, Spain
Rostov Na Donu, , Russian Federation
Amberg, , Germany
San Sebastian, Guipuzcoa, Spain
Waukesha, Wisconsin, United States
Green Bay, Wisconsin, United States
Belo Horizonte, Mg, Brazil
Porto Alegre, Rs, Brazil
Winnipeg, Manitoba, Canada
Brno, , Czechia
Ahaus, , Germany
Bamberg, , Germany
Delitzsch, , Germany
Hamm, , Germany
Homburg/Saar, , Germany
Kempten, , Germany
Koeln, , Germany
Landshut, , Germany
Lebach, , Germany
Nürnberg, , Germany
Rüsselsheim, , Germany
Sindelfingen, , Germany
Wendlingen, , Germany
Culiacan, , Mexico
Hermosillo, , Mexico
San Luis Potosi, , Mexico
Bucuresti, , Romania
Targu Mures, , Romania
Penza, , Russian Federation
Perm, , Russian Federation
Gandia, Valencia, Spain
Las Palmas, , Spain
Canterbury, , United Kingdom
Cottingham, , United Kingdom
Terni, Umbria, Italy
Cosenza, Calabria, Italy
Messina, Sicilia, Italy
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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