Studientherapie

Study will evaluate the efficacy of brentuximab vedotin in combination with lenalidomide and rituximab versus placebo in combination with lenalidomide and rituximab for the treatment of subjects with R/R DLBCL

Studienstatus

Rekrutierung gestartet/nimmt Patienten auf

Allgemeine Infos zum Antrag

Herr Edward Walsh
ewalsh@seagen.com

Seattle Genetics Inc. - SeaGen (Unternehmen, 12569)
Bothell

Study to marketing authorisation in Europe

PFSa per blinded independent central review (BICR) in the ITT population
PFS per BICR in the CD30-positive population

Subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

approx 400 subjects- 200 randomised to each arm

Evaluate and compare progression-free survival
(PFS) between the 2 treatment arms in the intent-to-treat (ITT) population

PFSa per blinded independent central review (BICR) in the ITT population
PFS per BICR in the CD30-positive population.

Evaluate and compare PFS between the 2 treatment arms in the CD30-positive population

Evaluate and compare the objective response rate (ORR) between the 2 treatment arms in the ITT population

ORR per BICR

Evaluate and compare overall survival (OS) between the 2 treatment arms in the ITT population
Evaluate and compare OS between the 2 treatment arms in the CD30-positive population

Spezifische Infos zum Antrag

refer to attached protocol Synopsis

refer to the attached protocol synopsis

Treatment may continue as long as there is clinical benefit (stable disease [SD] or better) without progression or unacceptable toxicity.

approx 150 sites globally incl approx 15-20 German sites

Seattle Genetics Inc.

Euro 8M

15

to be discussed

Ja

• Protocol Synopsis
   
• PSV Slides