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Brief Title: A Study of ABT-263 in Combination With Dose-Intensive Rituximab, or Dose-Intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)
Official Title: A Phase II, Multicenter, Randomized, Controlled, Open-label Study of the Safety, Efficacy and Pharmacokinetics of ABT-263 in Combination With Dose-intensive Rituximab, or Dose-intensive Rituximab Alone, in Previously Untreated Patients With B-Cell, Chronic Lymphocytic Leukemia (CLL)
Study ID: NCT01087151
Brief Summary: This Phase II, randomized, open-label, international, multicenter trial is designed to evaluate the safety and efficacy of rituximab monotherapy when given according to a dose intense regimen and to assess the safety, efficacy, and pharmacokinetics of ABT-263 when combined with dose-intense rituximab in previously untreated patients with B-cell CLL.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Alhambra, California, United States
, Antioch, California, United States
, Berkeley, California, United States
, Burbank, California, United States
, Duarte, California, United States
, Dublin, California, United States
, La Jolla, California, United States
, Los Angeles, California, United States
, Los Angeles, California, United States
, Los Angeles, California, United States
, Los Angeles, California, United States
, Northridge, California, United States
, Pleasant Hill, California, United States
, San Leandro, California, United States
, San Luis Obispo, California, United States
, Santa Monica, California, United States
, Fort Collins, Colorado, United States
, Norwalk, Connecticut, United States
, Bay Pines, Florida, United States
, Atlanta, Georgia, United States
, Chicago, Illinois, United States
, Decatur, Illinois, United States
, Harvey, Illinois, United States
, Tinley Park, Illinois, United States
, Shreverport, Louisiana, United States
, Baltimore, Maryland, United States
, Bethesda, Maryland, United States
, Bethesda, Maryland, United States
, Randallstown, Maryland, United States
, Lansing, Michigan, United States
, Lansing, Michigan, United States
, Omaha, Nebraska, United States
, Henderson, Nevada, United States
, Las Vegas, Nevada, United States
, Las Vegas, Nevada, United States
, Reno, Nevada, United States
, Cherry Hill, New Jersey, United States
, Farmington, New Mexico, United States
, Oneida, New York, United States
, Oswego, New York, United States
, Syracuse, New York, United States
, Middletown, Ohio, United States
, Philadelphia, Pennsylvania, United States
, Pittsburgh, Pennsylvania, United States
, Corpus Christi, Texas, United States
, Lubbock, Texas, United States
, Lubbock, Texas, United States
, Everett, Washington, United States
, Randwick, New South Wales, Australia
, Greenslopes, Queensland, Australia
, Adelaide, South Australia, Australia
, Kurralta Park, South Australia, Australia
, Coburg, VIC, Victoria, Australia
, Fitzroy, Victoria, Australia
, Frankston, Victoria, Australia
, Parkville, Victoria, Australia
, Fremantle, Western Australia, Australia
, Cachoeiro de Itapemirim, ES, Brazil
, Belo Horizonte, MG, Brazil
, Belo Horizonte, MG, Brazil
, Rio de Janeiro, RJ, Brazil
, Caxias do Sul, RS, Brazil
, Porto Alegre, RS, Brazil
, Porto Alegre, RS, Brazil
, Porto Alegre, RS, Brazil
, Santo Andre, SP, Brazil
, São Paulo, SP, Brazil
, Brno, , Czech Republic
, Hradec Kralove, , Czech Republic
, Prague 2, , Czech Republic
, Lille, , France
, Pierre Benite, , France
, Afula, , Israel
, Petah Tikva, , Israel
, Ramat Gan, , Israel
, Rehovot, , Israel
, Modena, Emilia-Romagna, Italy
, Genova, Liguria, Italy
, Cremona, Lombardia, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Rozzano, Lombardia, Italy
, Torino, Piemonte, Italy
, Chorzow, , Poland
, Gdansk, , Poland
, Warszawa, , Poland
, San Juan, , Puerto Rico
, Kazan, , Russian Federation
, Moscow, , Russian Federation
, Petrozavodsk, , Russian Federation
, Ryazan, , Russian Federation
, St. Petersburg, , Russian Federation
, Cherkassy, , Ukraine
, Dnipropetrovsk, , Ukraine
, Donetsk, , Ukraine
, Ivano-Frankivsk, , Ukraine
, Khmelnitskyy, , Ukraine
, Kyiv, , Ukraine
, Lviv, , Ukraine
, Poltava, , Ukraine
, Zhytomir, , Ukraine
, Leicester, , United Kingdom
, London, , United Kingdom
Name: William Ho, M.D., Ph.D.
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR