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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)
Sponsor: Janssen Research & Development, LLC
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).
Official title: A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
211
Start Date
2018-04-17
Completion Date
2029-04-05
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Ibrutinib
Participants will receive ibrutinib 420 mg orally once daily up to 15 cycles.
Venetoclax
Participants will receive venetoclax in combination with ibrutinib for a total of 12 cycles, beginning at Cycle 4. For the first 5 weeks of venetoclax treatment, the treatment dose will be ramped up from 20 to 400 mg.
Chlorambucil
Participants will receive chlorambucil at a dose of 0.5 mg/kg body weight on Days 1 and 15 of Cycles 1 to 6.
Obinutuzumab
Participant will receive obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, and Day 1 of Cycles 2 to 6.
Ibrutinib (as Subsequent Therapy)
Participants will receive ibrutinib 420 mg orally once daily until disease progression or unacceptable toxicity during the subsequent therapy phase.
Locations (87)
Norton Cancer Institute
Louisville, Kentucky, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Novant Health
Charlotte, North Carolina, United States
Institut - Jules Bordet
Anderlecht, Belgium
ZNA Stuivenberg
Antwerp, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Virga Jessa Ziekenhuis
Hasselt, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika
Brno, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
Pilsen, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Prague, Czechia
Aalborg University Hospital
Aalborg, Denmark
Aarhus Universitetshospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense Universitetshospital
Odense C, Denmark
Roskilde Sygehus
Roskilde, Denmark
CHU de Clermont Ferrand
Clermont-Ferrand, France
Hopital Claude Huriez
Lille, France
CHU Montpellier
Montpellier, France
Hopital Haut Leveque Service Maladie Du Sang
Pessac, France
Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré
Reims, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
CHU Bretonneau
Tours, France
CHU-Nancy
Vandœuvre-lès-Nancy, France
Institut Gustave Roussy
Villejuif, France
Bnai Zion Medical Center
Haifa, Israel
Carmel Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Western Galilee Medical Center
Nahariya, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Flevoziekenhuis
Almere Stad, Netherlands
OLVG
Amsterdam, Netherlands
Academic Medical Center
Amsterdam, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Catharinaziekenhuis
Eindhoven, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Zuyderland Medical Center
Sittard-Geleen, Netherlands
Antonius hospital
Sneek, Netherlands
MC Haaglanden
The Hague, Netherlands
Elisabeth zkh
Tilburg, Netherlands
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
Lodz, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
Lublin, Poland
Wojewodzki Szpital Specjalistyczny im Janusza Korczaka
Słupsk, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Poland
Moscow Multidisciplinary Scientific and Clinical Center named after S P Botkin
Moscow, Russia
S.P. Botkin Moscow City Clinical Hospital
Moscow, Russia
Nizhniy Novgorod Region Clinical Hospital
Nizhny Novgorod, Russia
Ryazan Regional Clinical Hospital
Ryazan, Russia
St.-Petersburg Clinical Research Institute of Hematology and Transfusiology
Saint Petersburg, Russia
FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF
Saint Petersburg, Russia
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Clinic de Barcelona
Barcelona, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain
Hosp. Univ. de La Princesa
Madrid, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp. Univ. Infanta Leonor
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hospital Clinico Universitario Salamanca
Salamanca, Spain
Hosp. Virgen Del Rocio
Seville, Spain
Sunderby Sjukhus Medicinkliniken
Luelå, Sweden
Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm
Stockholm, Sweden
Gazi Universitesi Tip Fakultesi
Ankara, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
Ankara, Turkey (Türkiye)
V K V Amerikan Hastanesi
Istanbul, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, Turkey (Türkiye)
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
Queen Mary University of London
Charterhouse Square, United Kingdom
New Victoria Hospital
Glasgow, United Kingdom
St James's Hospital
Leeds, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Barking Havering and Redbridge University Hospitals NHS Trust
Romford, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom