114
Participants
Start Date
February 26, 2019
Primary Completion Date
August 4, 2020
Study Completion Date
January 25, 2023
Obinutuzumab
Obinutuzumab 1000 mg IV infusion, administered on Day 1, 8 and 15 during Cycle 1, and on Day 1 of subsequent cycles, for 6-8 cycles. Each cycle is 21 or 28 days long depending on the chemotherapy regimen allocated. Maintenance obinutuzumab monotherapy in patients who achieve at least a partial response, after induction therapy will be administered a dose of 1000 mg once every 8 weeks for 2 years or until disease progression (whichever occurs first).
Bendamustine
Bendamustine will be administered on Days 1 and 2 for Cycles 1-6 at a dose of 90 mg/m2/day, for six 28-day cycles.
Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m\^2), administered intravenously (IV) on Day 1 of each 21-day cycle, for six cycles for CHOP treatment or eight cycles for CVP treatment.
Doxorubicin
Doxorubicin 50 mg/m\^2 IV, administered on Day 1 of each 21-day cycle, for six cycles.
Prednisone/Prednisolone/Methylprednisolone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle, for six cycles for CHOP treatment or eight cycles for CVP treatment.
Vincristine
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle, for six cycles for CHOP treatment or eight cycles for CVP treatment.
Hospital Universitario Puerta del Mar; Servicio de Hematologia, Cadiz
OncoResearch Lerchenfeld GmbH, Hamburg
Onkologische Schwerpunktpraxis Lübeck, Lübeck
Hospital Universitario la Paz; Servicio de Hematologia, Madrid
Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología, Murcia
Klinik der Uni zu Köln; I. Med. Klinik, Cologne
Universitätsklinikum Frankfurt; Medizinische Klinik II; Onkologie, Frankfurt
Texas Onc-Central Austin CA Ct, Austin
Texas Oncology Cancer Center, Austin
Rocky Mountain Cancer Center; Medical Oncology, Boulder
MVZ Dr. Vehling-Kaiser GmbH; Onkologische Praxis, Landshut
San Juan Oncology Associates, Farmington
American Oncology Partners of Maryland, PA, Bethesda
Summit Medical Center, Florham Park
Willamette Valley Cancer Ctr - 520 Country Club, Eugene
NOHC - Núcleo de Oncologia e Hematologia do Ceará, Fortaleza
Hospital das Clinicas - UFRGS, Porto Alegre
Hospital Amaral Carvalho, Jaú
Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III, Hämatologie und Onkologie, Chemnitz
Städtisches Klinikum Dessau, Dessau
Chiba Cancer Center, Chiba
Hokkaido University Hospital, Hokkaido
Kobe City Medical Center General Hospital, Hyōgo
Kindai University Hospital, Osaka
National Cancer Center Hospital, Tokyo
The Cancer Institute Hospital of JFCR, Tokyo
Albert Schweitzer Ziekenhuis - loc Dordrecht, Dordrecht
Martini Ziekenhuis, Groningen
Hospital De Txagorritxu; Servicio de Hematologia, Vitoria-Gasteiz
Hospital del Mar; Servicio de Hematologia, Barcelona
University Hospital of Wales, Cardiff
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital, Portsmouth
Royal Cornwall Hospital, Truro
Hoffmann-La Roche
INDUSTRY