Chronic Lymphocytic Leukemia Clinical Trial
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Summary
The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).
Full Description
The hypothesis is treatment with combination of I+VEN will result in longer PFS compared with G-Clb in participants with previously untreated leukemia-cll/" >chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) who meet International Workshop on CLL (iwCLL) treatment criteria. The study includes screening (30 days), treatment (from randomization until treatment discontinuation) and follow-up phase (from treatment discontinuation until Subsequent Therapy Phase [if applicable], death, lost to follow up, consent withdrawal, or study end, whichever occurs first). Participants without progression will continue disease evaluations until disease progression or death. Participants from either treatment arm that develop progressive disease may be eligible to receive single-agent ibrutinib until disease progression or unacceptable toxicity (Subsequent Therapy Phase). Participation in this phase of the study is not mandatory and is based on investigator's discretion. Study duration is approximately 6 years. Safety includes review of adverse events and laboratory tests performed over time.
Eligibility Criteria
Inclusion Criteria:
Adult participants who are: (a) greater than or equal to (>=) 65 years old or, (b) 18 to 64 years old and have at least 1 of the following:
Cumulative Illness Rating Scale (CIRS) score > 6
Creatinine clearance (CrCl) estimated less than (<) 70 milliliter per minute (mL/min) using Cockcroft-Gault equation
Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
Measurable nodal disease (by computed tomography [CT]), defined as at least one lymph node > 1.5 centimeter (cm) in longest diameter
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (<=) 2
Active CLL/SLL requiring treatment per the iwCLL criteria
Exclusion Criteria:
Prior anti-leukemic therapy for CLL or SLL
Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53 mutation detected at a threshold of >10 percent (%) variable allele frequency (VAF)
Major surgery within 4 weeks of first dose of study treatment
Known bleeding disorders (example, von Willebrand's disease or hemophilia)
Central nervous system (CNS) involvement or suspected Richter's syndrome
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There are 85 Locations for this study
Louisville Kentucky, 40207, United States
Hackensack New Jersey, 07601, United States
Charlotte North Carolina, 28204, United States
Anderlecht , 1070, Belgium
Antwerpen , 2060, Belgium
Gent , 9000, Belgium
Hasselt , 3500, Belgium
Leuven , 3000, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Hamilton Ontario, L8V 5, Canada
Ottawa Ontario, K1H 8, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H3T 1, Canada
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Ostrava , 708 5, Czechia
Plzen , 323 0, Czechia
Praha 2 , 128 0, Czechia
Aalborg , 9000, Denmark
Aarhus , 8200, Denmark
Copenhagen , 2100, Denmark
Odense C , 5000, Denmark
Roskilde , DK- 4, Denmark
Clermont Ferrand , 63000, France
Lille , 59000, France
Montpellier , 34295, France
Pessac , 33604, France
Reims , 51100, France
Toulouse Cedex 9 , 31059, France
Tours Cedex 9 , 37044, France
Vandoeuvre les Nancy , 54511, France
Villejuif , 94805, France
Haifa , 31048, Israel
Haifa , 34362, Israel
Jerusalem , 91120, Israel
Nahariya , 22100, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Almere , 1315R, Netherlands
Amsterdam , 1091A, Netherlands
Amsterdam , 1105 , Netherlands
Delft , 2625 , Netherlands
Den Haag , 2512 , Netherlands
Dordrecht , 3318 , Netherlands
Eindhoven , 5623 , Netherlands
Hoofddorp , 2134 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Sneek , 8601 , Netherlands
Tilburg , 5022 , Netherlands
Chorzów , 41-50, Poland
Lodz , 93-51, Poland
Lublin , 20-08, Poland
Slupsk , 76-20, Poland
Warszawa , 02-77, Poland
Moscow , 12528, Russian Federation
Nizhny Novgorod , 60312, Russian Federation
Ryazan , 39003, Russian Federation
Saint Petersburg , 19734, Russian Federation
St. Petersburg , 19302, Russian Federation
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 8041, Spain
Madrid , 28006, Spain
Madrid , 28007, Spain
Madrid , 28031, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Sevilla , 41013, Spain
Luelå , 97180, Sweden
Stockholm , 171 7, Sweden
Ankara , 06500, Turkey
Ankara , 6590, Turkey
Atakum , 55270, Turkey
Istanbul , 34365, Turkey
Izmir , 35340, Turkey
Birmingham , B9 5S, United Kingdom
Cambridge , CB2 0, United Kingdom
Charterhouse Square , EC1M , United Kingdom
Glasgow , G42 9, United Kingdom
Leeds , LS9 7, United Kingdom
Plymouth , PL6 8, United Kingdom
Romford , RM7 0, United Kingdom
Sheffield , S10 2, United Kingdom
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