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A Study to Compare the Efficacy and Safety of Obinutuzumab + Venetoclax (GDC-0199) Versus Obinutuzumab + Chlorambucil in Participants With Chronic Lymphocytic Leukemia
- Chronic Lymphocytic Leukemia
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Aachen
- Adelaide
- Amberg
- Atlanta
- Barcelona
- Berlin
- Bern
- Besançon
- Białystok
- Birmingham
- Boston
- Box Hill
- București
- Buenos Aires
- Caen
- Calgary
- chirignago-zelarino
- Chorzów
- Christchurch
- Clayton
- Clermont-Ferrand
- Créteil
- Culiacán Rosales
- Detroit
- Dijon
- Douglas
- Dresden
- Duarte
- Dunedin
- Edinburgh
- emilia-romagna
- Encinitas
- Epping
- Essen
- Esslingen am Neckar
- Frankfurt (Oder)
- Freiburg im Breisgau
- Gilbert
- glandore
- Göttingen
- Halifax
- Harvey
- Heidelberg
- Herlev
- Herne
- Iași
- Innsbruck
- Kazan
- Koblenz
- Köln
- København
- La Tronche
- Landshut
- Le Mans
- Lincoln
- Liverpool
- Lubbock
- Luzern 16
- Lyon
- Madrid
- Messina
- Milano
- Montpellier
- Montréal
- Moskva
- Mutlangen
- Mönchengladbach
- München
- Nantes
- Neunkirchen
- Nizhny Novgorod
- Paderborn
- Palmerston North
- Pamplona
- Paris
- Penza
- Perm
- Pleven
- Plovdiv
- Regensburg
- Rennes
- Rio Grande do Sul
- Roma
- Roskilde
- Rostov
- Rouen
- Salamanca
- San Cristóbal de La Laguna
- San Diego
- Sevilla
- Sofia
- Southampton
- Stuttgart
- São Paulo
- Słupsk
- Tallinn
- Tampa
- Tartu
- Terni
- Toledo
- Torino
- Toulon
- Tweed Heads
- Târgu Mureș
- Tübingen
- Ufa
- Ulm
- ustka
- València
- Vejle
- Villejuif
- Vratsa
- Weiden in der Oberpfalz
- Wellington
- Wien
- Woolloongabba
- Wrocław
- Zagreb
- Zürich
- Łódź
Trial Identifier:
NCT02242942 2014-001810-24, CLL14 BO25323
Trial 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 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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02242942 , BO25323 , 2014-001810-24, CLL14
Trial Identifier
Chlorambucil, Venetoclax, Obinutuzumab
Treatments
Lymphocytic Leukemia, Chronic
Condition
Official Title
A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com