Spots Global Cancer Trial Database for Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
Official Title: A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Added to Chlorambucil Versus Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
Study ID: NCT00748189
Conditions
Study Description
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.
Detailed Description: Chlorambucil, is currently approved for treatment of frontline chronic lymphocytic leukemia, especially, but not limited to the ailing and elderly patient population. Several other more aggressive treatment options are available (e.g. fludarabine), however they are not suitable for all CLL patients, especially the ailing and elderly, due to greater toxicity. Ofatumumab is effective with low toxicity. The addition of ofatumumab to chlorambucil offers potentially a more effective therapy, with limited toxicity. The objective of this study was to evaluate progression-free survival (PFS), overall response and overall survival in subjects with previously untreated CLL with ofatumumab added to chlorambucil versus chlorambucil.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Sedona, Arizona, United States
Novartis Investigative Site, Tucson, Arizona, United States
Novartis Investigative Site, Murrieta, California, United States
Novartis Investigative Site, Aurora, Colorado, United States
Novartis Investigative Site, Denver, Colorado, United States
Novartis Investigative Site, Boca Raton, Florida, United States
Novartis Investigative Site, New Port Richey, Florida, United States
Novartis Investigative Site, Ocala, Florida, United States
Novartis Investigative Site, Ocoee, Florida, United States
Novartis Investigative Site, Marietta, Georgia, United States
Novartis Investigative Site, Chicago, Illinois, United States
Novartis Investigative Site, Indianapolis, Indiana, United States
Novartis Investigative Site, Lee's Summit, Missouri, United States
Novartis Investigative Site, Raleigh, North Carolina, United States
Novartis Investigative Site, Abilene, Texas, United States
Novartis Investigative Site, Arlington, Texas, United States
Novartis Investigative Site, Austin, Texas, United States
Novartis Investigative Site, Dallas, Texas, United States
Novartis Investigative Site, Dallas, Texas, United States
Novartis Investigative Site, Fort Worth, Texas, United States
Novartis Investigative Site, Midland, Texas, United States
Novartis Investigative Site, Odessa, Texas, United States
Novartis Investigative Site, San Antonio, Texas, United States
Novartis Investigative Site, San Antonio, Texas, United States
Novartis Investigative Site, Tyler, Texas, United States
Novartis Investigative Site, Waco, Texas, United States
Novartis Investigative Site, Webster, Texas, United States
Novartis Investigative Site, Seattle, Washington, United States
Novartis Investigative Site, Vancouver, Washington, United States
Novartis Investigative Site, Yakima, Washington, United States
Novartis Investigative Site, Brugge, , Belgium
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Haine-Saint-Paul, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Porto Alegre, Rio De Janeiro, Brazil
Novartis Investigative Site, Sao Paulo, São Paulo, Brazil
Novartis Investigative Site, Sao Paulo, São Paulo, Brazil
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Sherbrooke, Quebec, Canada
Novartis Investigative Site, Brno, , Czechia
Novartis Investigative Site, Hradec Kralove, , Czechia
Novartis Investigative Site, Praha 10, , Czechia
Novartis Investigative Site, Creteil, , France
Novartis Investigative Site, Pierre Benite, , France
Novartis Investigative Site, Karlsruhe, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Mannheim, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Stuttgart, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Ulm, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Erlangen, Bayern, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Regensburg, Bayern, Germany
Novartis Investigative Site, Wuerzburg, Bayern, Germany
Novartis Investigative Site, Frankfurt, Hessen, Germany
Novartis Investigative Site, Kassel, Hessen, Germany
Novartis Investigative Site, Hannover, Niedersachsen, Germany
Novartis Investigative Site, Lehrte, Niedersachsen, Germany
Novartis Investigative Site, Essen, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Moenchengladbach-Rheydt, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Muenster, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Saarbruecken, Saarland, Germany
Novartis Investigative Site, Athens,, , Greece
Novartis Investigative Site, Thessaloniki, , Greece
Novartis Investigative Site, Thessaloniki, , Greece
Novartis Investigative Site, Ahmedabad, , India
Novartis Investigative Site, Bangalore, , India
Novartis Investigative Site, Mumbai, , India
Novartis Investigative Site, Mumbai, , India
Novartis Investigative Site, New Delhi, , India
Novartis Investigative Site, Pune, , India
Novartis Investigative Site, Cork, , Ireland
Novartis Investigative Site, Dublin, , Ireland
Novartis Investigative Site, Galway, , Ireland
Novartis Investigative Site, James Street, , Ireland
Novartis Investigative Site, Limerick, , Ireland
Novartis Investigative Site, Tullamore, , Ireland
Novartis Investigative Site, Waterford, , Ireland
Novartis Investigative Site, Potenza, Basilicata, Italy
Novartis Investigative Site, Napoli, Campania, Italy
Novartis Investigative Site, Albano Laziale (Roma), Lazio, Italy
Novartis Investigative Site, Genova, Liguria, Italy
Novartis Investigative Site, Brescia, Lombardia, Italy
Novartis Investigative Site, Milano, Lombardia, Italy
Novartis Investigative Site, Milano, Lombardia, Italy
Novartis Investigative Site, Milano, Lombardia, Italy
Novartis Investigative Site, Ascoli Piceno, Marche, Italy
Novartis Investigative Site, Novara, Piemonte, Italy
Novartis Investigative Site, Bari, Puglia, Italy
Novartis Investigative Site, Palermo, Sicilia, Italy
Novartis Investigative Site, Venezia - Mestre, Veneto, Italy
Novartis Investigative Site, Vicenza, Veneto, Italy
Novartis Investigative Site, Udine, , Italy
Novartis Investigative Site, Amersfoort, , Netherlands
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Den Haag, , Netherlands
Novartis Investigative Site, Groningen, , Netherlands
Novartis Investigative Site, Nijmegen, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Bialystok, , Poland
Novartis Investigative Site, Chorzow, , Poland
Novartis Investigative Site, Lodz, , Poland
Novartis Investigative Site, Slupsk, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Wroclaw, , Poland
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Novosibirsk, , Russian Federation
Novartis Investigative Site, St'Petersburg, , Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Hospitalet de Llobregat (Barcelona), , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Salamanca, , Spain
Novartis Investigative Site, Valencia, , Spain
Novartis Investigative Site, Lulea, , Sweden
Novartis Investigative Site, Stockholm, , Sweden
Novartis Investigative Site, Uppsala, , Sweden
Novartis Investigative Site, Plymouth, Devon, United Kingdom
Novartis Investigative Site, Taunton, Somerset, United Kingdom
Novartis Investigative Site, Sunderland, Tyne, United Kingdom
Novartis Investigative Site, Bath, , United Kingdom
Novartis Investigative Site, Belfast, , United Kingdom
Novartis Investigative Site, Birmingham, , United Kingdom
Novartis Investigative Site, Bournemouth, , United Kingdom
Novartis Investigative Site, Bradford, , United Kingdom
Novartis Investigative Site, Cambridge, , United Kingdom
Novartis Investigative Site, Canterbury, Kent, , United Kingdom
Novartis Investigative Site, Carshalton, , United Kingdom
Novartis Investigative Site, Cornwall, , United Kingdom
Novartis Investigative Site, Dudley, , United Kingdom
Novartis Investigative Site, Exeter, , United Kingdom
Novartis Investigative Site, Glasgow, , United Kingdom
Novartis Investigative Site, Leeds, , United Kingdom
Novartis Investigative Site, Liverpool, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Novartis Investigative Site, Milton Keynes, , United Kingdom
Novartis Investigative Site, Newcastle-upon-Tyne, , United Kingdom
Novartis Investigative Site, Norwich, , United Kingdom
Novartis Investigative Site, Oxford, , United Kingdom
Novartis Investigative Site, Peterborough, , United Kingdom
Novartis Investigative Site, Rhyl, Denbighshire, , United Kingdom
Novartis Investigative Site, Salford, , United Kingdom
Novartis Investigative Site, Stoke on Trent, , United Kingdom
Novartis Investigative Site, Swindon, , United Kingdom
Novartis Investigative Site, Uxbridge, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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