A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

February 28, 2017

Primary Completion Date

April 24, 2022

Study Completion Date

April 24, 2022

Conditions
Lymphoma, Large B-Cell, Diffuse
Interventions
DRUG

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."

DRUG

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.

DRUG

Doxorubicin

A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.

DRUG

Vincristine

A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.

DRUG

Cyclophosphamide

A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.

DRUG

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."

DRUG

Lenalidomide

Lenalidomide was administered orally in capsule form on Days 1-14 of the DUR+R2-CHOP treatment arm only.

Trial Locations (20)

1140

Hanusch Krankenhaus, Vienna

1190

Local Institution - 101, Vienna

Medical University of Vienna Internalmedicine 1, Hematology, Vienna

2100

Rigshospitalet, Kobenhavns Universitet - Centre for Clinical Intervention Research - The Copenhagen, Copenhagen

5020

Landeskrankenhaus Salzburg, Salzburg

6020

Innsbruck Medical University Department of Internal Medicine, Innsbruck

13419

(North Estonia Medical Centre) - Onkoloogia-ja Hematoloogiakliinik, Tallinn

14263

Roswell Park Cancer Institute, Buffalo

14642

University of Rochester Medical Center, Rochester

43219

Mid Ohio Oncology Hematology Inc, Columbus

46845

Parkview Research Center, Fort Wayne

51014

Tartu University Hospital, Tartu

55905

Mayo Clinic, Rochester

85234

Banner MD Anderson Cancer Center, Gilbert

98104

Swedish Cancer Institute, Seattle

DK-8000

Aarhus Sygehus, Arhus C

DK5000

Odense Universitetshospital, Odense C

B15 2TH

University Hospital Birmingham, Birmingham

SW3 6JJ

Royal Marsden Hospital, London

0X3 7LE

Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY