211
Participants
Start Date
April 17, 2018
Primary Completion Date
February 26, 2021
Study Completion Date
April 5, 2029
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.
Institut - Jules Bordet, Anderlecht
ZNA Stuivenberg, Antwerp
Rigshospitalet, Copenhagen
UZ Leuven Gasthuisberg, Leuven
Virga Jessa Ziekenhuis, Hasselt
Odense Universitetshospital, Odense C
Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi, Ankara
Hosp. de La Santa Creu I Sant Pau, Barcelona
Aarhus Universitetshospital, Aarhus
Universitair Ziekenhuis Gent, Ghent
Aalborg University Hospital, Aalborg
Western Galilee Medical Center, Nahariya
Hosp. Univ. de La Princesa, Madrid
Hosp. Gral. Univ. Gregorio Maranon, Madrid
Hosp. Univ. Infanta Leonor, Madrid
Hospital Ramon y Cajal, Madrid
Hosp Univ Fund Jimenez Diaz, Madrid
Novant Health, Charlotte
Clinica Univ. de Navarra, Pamplona
Bnai Zion Medical Center, Haifa
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse
Hopital Haut Leveque Service Maladie Du Sang, Pessac
CHU Montpellier, Montpellier
Carmel Medical Center, Haifa
V K V Amerikan Hastanesi, Istanbul
Dokuz Eylul Universitesi Tip Fakultesi, Izmir
Hospital Clinico Universitario Salamanca, Salamanca
CHU Bretonneau, Tours
Norton Cancer Institute, Louisville
Hosp. Virgen Del Rocio, Seville
Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré, Reims
Sheba Medical Center, Ramat Gan
CHU-Nancy, Vandœuvre-lès-Nancy
Ondokuz Mayis University, Atakum
Hopital Claude Huriez, Lille
CHU de Clermont Ferrand, Clermont-Ferrand
Tel Aviv Sourasky Medical Center, Tel Aviv
Institut Gustave Roussy, Villejuif
Sunderby Sjukhus Medicinkliniken, Luelå
Moscow Multidisciplinary Scientific and Clinical Center named after S P Botkin, Moscow
S.P. Botkin Moscow City Clinical Hospital, Moscow
St.-Petersburg Clinical Research Institute of Hematology and Transfusiology, Saint Petersburg
FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF, Saint Petersburg
Ryazan Regional Clinical Hospital, Ryazan
Nizhniy Novgorod Region Clinical Hospital, Nizhny Novgorod
Hadassah Medical Center, Jerusalem
John Theurer Cancer Center, Hackensack
Arthur J E Child Comprehensive Cancer Centre, Calgary
Cross Cancer Institute, Edmonton
Juravinski Cancer Centre, Hamilton
The Ottawa Hospital - General Campus, Ottawa
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont, Montreal
Jewish General Hospital, Montreal
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika, Brno
Fakultni nemocnice Hradec Kralove, Hradec Králové
Fakultni Nemocnice Ostrava, Ostrava
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni, Pilsen
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie, Prague
Roskilde Sygehus, Roskilde
Flevoziekenhuis, Almere Stad
OLVG, Amsterdam
Academic Medical Center, Amsterdam
Reinier de Graaf Gasthuis, Delft
Albert Schweitzer Ziekenhuis, Dordrecht
Catharinaziekenhuis, Eindhoven
Spaarne Gasthuis, Hoofddorp
Zuyderland Medical Center, Sittard-Geleen
Antonius hospital, Sneek
MC Haaglanden, The Hague
Elisabeth zkh, Tilburg
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich, Chorzów
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi, Lodz
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie, Lublin
Wojewodzki Szpital Specjalistyczny im Janusza Korczaka, Słupsk
Instytut Hematologii i Transfuzjologii, Warsaw
Hosp Univ Vall D Hebron, Barcelona
Hosp Clinic de Barcelona, Barcelona
Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm, Stockholm
Gazi Universitesi Tip Fakultesi, Ankara
Birmingham Heartlands Hospital, Birmingham
Addenbrookes Hospital, Cambridge
Queen Mary University of London, Charterhouse Square
New Victoria Hospital, Glasgow
St James's Hospital, Leeds
Derriford Hospital, Plymouth
Barking Havering and Redbridge University Hospitals NHS Trust, Romford
Royal Hallamshire Hospital, Sheffield
Collaborators (1)
Pharmacyclics LLC.
INDUSTRY
Janssen Research & Development, LLC
INDUSTRY