46
Participants
Start Date
February 28, 2017
Primary Completion Date
April 24, 2022
Study Completion Date
April 24, 2022
Durvalumab
"Durvalumab was supplied in single use vials as a liquid solution containing 500 mg (nominal) of durvalumab at a concentration of 50 mg/mL to be infused by intravenous (IV) injection.~Day 1 of each treatment cycle (Induction Period and Consolidation Period) started with the administration of IV durvalumab followed by a 2-hour observation period post infusion."
Rituximab
Subsequent to durvalumab infusion, rituximab was administered by IV. Rituximab administration could be split over 2 consecutive days according to local clinical practice. Rapid infusion of rituximab was not allowed in this clinical study.
Doxorubicin
A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.
Vincristine
A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.
Cyclophosphamide
A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.
Prednisone
"Prednisone was administered as an IV infusion or by mouth (PO) on Day 1, followed by PO administration on Days 2-5 of each cycle.~Prednisone could be given prior to other drugs of the CHOP therapy. It was administered after lenalidomide dosing in the R2-CHOP treatment arm."
Lenalidomide
Lenalidomide was administered orally in capsule form on Days 1-14 of the DUR+R2-CHOP treatment arm only.
Hanusch Krankenhaus, Vienna
Local Institution - 101, Vienna
Medical University of Vienna Internalmedicine 1, Hematology, Vienna
Rigshospitalet, Kobenhavns Universitet - Centre for Clinical Intervention Research - The Copenhagen, Copenhagen
Landeskrankenhaus Salzburg, Salzburg
Innsbruck Medical University Department of Internal Medicine, Innsbruck
(North Estonia Medical Centre) - Onkoloogia-ja Hematoloogiakliinik, Tallinn
Roswell Park Cancer Institute, Buffalo
University of Rochester Medical Center, Rochester
Mid Ohio Oncology Hematology Inc, Columbus
Parkview Research Center, Fort Wayne
Tartu University Hospital, Tartu
Mayo Clinic, Rochester
Banner MD Anderson Cancer Center, Gilbert
Swedish Cancer Institute, Seattle
Aarhus Sygehus, Arhus C
Odense Universitetshospital, Odense C
University Hospital Birmingham, Birmingham
Royal Marsden Hospital, London
Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine, Oxford
Lead Sponsor
Celgene
INDUSTRY