Chronic Lymphocytic Leukemia Clinical Trial
Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia
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 leukemia-cll/" >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.
Eligibility Criteria
Inclusion Criteria:
Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
CLL requiring treatment according to IWCLL criteria
Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6
Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
Adequate liver function
Life expectancy > 6 months
Agreement to use highly effective contraceptive methods per protocol
Exclusion Criteria:
Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
Known central nervous system involvement
Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
Inadequate renal function
History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy
Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients
Pregnant women and nursing mothers
Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
Requires the use of warfarin, marcumar, or phenprocoumon
Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug
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There are 132 Locations for this study
Gilbert Arizona, 85234, United States
Duarte California, 91010, United States
Encinitas California, 92024, United States
La Jolla California, 92093, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Harvey Illinois, 60426, United States
Detroit Michigan, 48202, United States
Lubbock Texas, 79410, United States
Buenos Aires , C1181, Argentina
Liverpool New South Wales, 2170, Australia
Tweed Heads New South Wales, 2485, Australia
Douglas Queensland, 4814, Australia
Woolloongabba Queensland, 4102, Australia
Adelaide South Australia, 5000, Australia
Ashford South Australia, 5035, Australia
Box Hill Victoria, 3128, Australia
Epping Victoria, VIC 3, Australia
Melbourne Victoria, 3168, Australia
Innsbruck , 6020, Austria
Wien , 1090, Austria
Wien , 1140, Austria
Wien , 1160, Austria
Porto Alegre RS, 90035, Brazil
Sao Paulo SP, 01236, Brazil
Sao Paulo SP, 01308, Brazil
Sao Paulo SP, 05403, Brazil
Sao Paulo SP, 08270, Brazil
Pleven , 5800, Bulgaria
Plovdiv , 4002, Bulgaria
Plovdiv , 4002, Bulgaria
Sofia , 1431, Bulgaria
Vratsa , 3000, Bulgaria
Calgary Alberta, T2N 4, Canada
Halifax Nova Scotia, B3H 2, Canada
Montreal Quebec, H3T 1, Canada
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Herlev , 2730, Denmark
København Ø , 2100, Denmark
Roskilde , 4000, Denmark
Vejle , 7100, Denmark
Tallinn , 13419, Estonia
Tartu , 51014, Estonia
Besançon Cedex , 25030, France
Caen , 14000, France
Clermont Ferrand , 63003, France
Creteil , 94000, France
Dijon , 21000, France
Grenoble , 38043, France
Le Mans , 72015, France
Lyon , 69373, France
Montpellier , 34295, France
Nantes , 44093, France
Paris , 75475, France
Rennes , 35033, France
Rouen , 76038, France
Toulon , 83056, France
Villejuif , 94805, France
Aachen , 52074, Germany
Amberg , 92224, Germany
Berlin , 12203, Germany
Berlin , 13353, Germany
Dresden , 01307, Germany
Dresden , 01307, Germany
Essen , 45122, Germany
Esslingen , 73730, Germany
Frankfurt/Oder , 15236, Germany
Freiburg , 79106, Germany
Göttingen , 37075, Germany
Heidelberg , 69120, Germany
Herne , 44625, Germany
Koblenz , 56068, Germany
Köln , 50931, Germany
Landshut , 84028, Germany
Munchen , 81675, Germany
Mutlangen , 73557, Germany
Mönchengladbach , 41063, Germany
München , 80804, Germany
München , 81377, Germany
Neunkirchen/Saar , 66538, Germany
Paderborn , 33098, Germany
Regensburg , 93049, Germany
Stuttgart , 70199, Germany
Stuttgart , 70376, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Weiden , 92367, Germany
Ferrara Emilia-Romagna, 44100, Italy
Messina Lazio, 98158, Italy
Roma Lazio, 00168, Italy
Torino Lazio, 10126, Italy
Milano Lombardia, 20132, Italy
Terni Umbria, 05100, Italy
Venezia Mestre Veneto, 30174, Italy
Culiacan Sinaloa, 80230, Mexico
Christchurch , 8011, New Zealand
Dunedin , , New Zealand
Palmerston North , 4442, New Zealand
Wellington , 6012, New Zealand
Bialystok , 15-2, Poland
Chorzów , 41-50, Poland
Lodz , 9351, Poland
Slupsk , 76-20, Poland
Wroclaw , 5036, Poland
Bucharest , 02232, Romania
Iasi , 70048, Romania
Targu-mures , 54013, Romania
UFA Baskortostan, 45000, Russian Federation
Moscow Moskovskaja Oblast, 12318, Russian Federation
Nizhny Novgorod Niznij Novgorod, 60312, Russian Federation
Rostov-na-donu Rostov, 34402, Russian Federation
Kazan Tatarstan, 42002, Russian Federation
Penza , 44007, Russian Federation
Perm , 61407, Russian Federation
Pamplona Navarra, 31008, Spain
La Laguna Tenerife, 38320, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28006, Spain
Madrid , 28034, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Toledo , 45004, Spain
Valencia , 46010, Spain
Valencia , 46015, Spain
Bern , 3010, Switzerland
Luzern , 6000, Switzerland
Zürich , 8091, Switzerland
Birmingham , B9 5S, United Kingdom
Boston,Lincolnshire , PE21 , United Kingdom
Edinburgh , EH4 2, United Kingdom
Lincoln , LN2 5, United Kingdom
Southhampton , SO16 , United Kingdom
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