Spots Global Cancer Trial Database for A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
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Trial Identification
Brief Title: A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Official Title: A Randomized, Multi-center, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Study ID: NCT02264574
Study Description
Brief Summary: The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site Reference ID/Investigator# 0241, La Jolla, California, United States
Site Reference ID/Investigator# 0844, Fort Myers, Florida, United States
Site Reference ID/Investigator# 0763, West Palm Beach, Florida, United States
Site Reference ID/Investigator# 071, Louisville, Kentucky, United States
Site Reference ID/Investigator# 0712, Las Vegas, Nevada, United States
Site Reference ID/Investigator# 0845, Cincinnati, Ohio, United States
Site Reference ID/Investigator# 0868, Chattanooga, Tennessee, United States
Site Reference ID/Investigator# 0123, Nashville, Tennessee, United States
Site Reference ID/Investigator #0503, Woolloongabba, Queensland, Australia
Site Reference ID/Investigator# 0650, Adelaide, South Australia, Australia
Site Reference ID/Investigator# 0888, Ballarat, Victoria, Australia
Site Reference ID/Investigator# 0193, Box Hill, Victoria, Australia
Site Reference ID/Investigator# 0633, Fitzroy, Victoria, Australia
Site Reference ID/Investigator# 0170, Heidelberg, Victoria, Australia
Site Reference ID/Investigator# 0352, Linz, , Austria
Site Reference ID/Investigator# 0869, Salzburg, , Austria
Site Reference ID/Investigator# 0559, Leuven, , Belgium
Site Reference ID/Investigator# 0850, Turnhout, , Belgium
Site Reference ID/Investigator# 018, Edmonton, Alberta, Canada
Site Reference ID/Investigator# 0564, Hradec Kralove, , Czechia
Site Reference ID/Investigator# 0854, Praha 10, , Czechia
Site Reference ID/Investigator# 0769, Pessac cedex, Gironde, France
Site Reference ID/Investigator# 0520, Nantes cedex 1, Loire Atlantique, France
Site Reference ID/Investigator# 0775, Vandoeuvre les Nancy, Meurthe Et Moselle, France
Site Reference ID/Investigator# 0855, Bayonne, Pyrenees Atlantiques, France
Site Reference ID/Investigator# 0573, Haifa, , Israel
Site Reference ID/Investigator# 0577, Jerusalem, , Israel
Site Reference ID/Investigator# 0579, Jerusalem, , Israel
Site Reference ID/Investigator# 0575, Petach Tikva, , Israel
Site Reference ID/Investigator# 0856, Tel Aviv, , Israel
Site Reference ID/Investigator# 0875, Zerifin, , Israel
Site Reference ID/Investigator# 0860, Firenze, , Italy
Site Reference ID/Investigator# 0523, Milano, , Italy
Site Reference ID/Investigator# 0581, Milano, , Italy
Site Reference ID/Investigator# 0584, Milano, , Italy
Site Reference ID/Investigator# 0524, Modena, , Italy
Site Reference ID/Investigator# 0582, Novara, , Italy
Site Reference ID/Investigator# 0732, Roma, , Italy
Site Reference ID/Investigator# 0859, Siena, , Italy
Site Reference ID/Investigator# 0663, Auckland, , New Zealand
Site Reference ID/Investigator# 662, Auckland, , New Zealand
Site Reference ID/Investigator# 0586, Hamilton, , New Zealand
Site Reference ID/Investigator# 0592, Brzozow, , Poland
Site Reference ID/Investigator# 0531, Lodz, , Poland
Site Reference ID/Investigator# 0708, Nizhniy Novgorod, , Russian Federation
Site Reference ID/Investigator# 0707, Ryazan, , Russian Federation
Site Reference ID/Investigator# 0881, Saint-Petersburg, , Russian Federation
Site Reference ID/Investigator# 710, St. Petersburg, , Russian Federation
Site Reference ID/Investigator# 304, Yaroslavl, , Russian Federation
Site Reference ID/Investigator# 0604, L'Hospitalet de Llobregat, Madrid, Spain
Site Reference ID/Investigator# 0536, Majadahonda, Madrid, Spain
Site Reference ID/Investigator# 0533, Barcelona, , Spain
Site Reference ID/Investigator# 0534, Barcelona, , Spain
Site Reference ID/Investigator# 0535, Barcelona, , Spain
Site Reference ID/Investigator# 0537, Madrid, , Spain
Site Reference ID/Investigator# 0864, Madrid, , Spain
Site Reference ID/Investigator# 0874, Madrid, , Spain
Site Reference ID/Investigator# 0790, Salamanca, , Spain
Site Reference ID/Investigator# 0870, Borås, , Sweden
Site Reference ID/Investigator# 0865, Luleå, , Sweden
Site Reference ID/Investigator# 0631, Lund, , Sweden
Site Reference ID/Investigator# 0632, Stockholm, , Sweden
Site Reference ID/Investigator# 0678, Istanbul, Nisantasi, Turkey
Site Reference ID/Investigator# 0608, Ankara, , Turkey
Site Reference ID/Investigator# 606, Ankara, , Turkey
Site Reference ID/Investigator# 0889, Denizli, , Turkey
Site Reference ID/Investigator# 0601, Izmir, , Turkey
Site Reference ID/Investigator# 0866, Samsun, , Turkey
Site Reference ID/Investigator# 0867, Harlow, Essex, United Kingdom
Site Reference ID/Investigator# 0365, London, , United Kingdom
Site Reference ID/Investigator# 0543, London, , United Kingdom
Contact Details
Name: Lori Styles
Affiliation: Pharmacyclics LLC.
Role: STUDY_DIRECTOR
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