Clinical trialNCT01925612TerminatedPhase 2Interventional

Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)

SponsorSeagen Inc.Enrollment87Lymphoma, B-cellLymphoma, Large B-cell, Diffuse

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study has 3 parts. The purpose of Part 1 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) (known as BV+RCHOP) in patients with DLBCL who have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive RCHOP together with 1 of 2 doses of brentuximab vedotin. Patients will be tested to see if there is a difference in side effects between the 2 groups. The purpose of Part 2 of this study is to assess the safety and efficacy of brentuximab vedotin in combination with RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) (known as BV+RCHP) in patients with CD30-positive DLBCL who have never been treated. Patients will be enrolled to receive RCHP together with 1.8mg/kg of brentuximab vedotin. The purpose of Part 3 of this study is to assess the safety and efficacy of BV+RCHP compared to standard RCHOP in patients with CD30-positive DLBCL that have never been treated. Patients will be randomly assigned in a 1:1 ratio to receive either BV+RCHP or RCHOP. Patients will be tested to see if there is a difference in side effects between the 2 groups.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Katherine Ruffner
Seagen Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

51 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Czechia

Fakultni Nemocnice Brno
Brno, Czechia
Fakultni Nemocnice Hradec Kralove-Oddeleni Klinicke Hematologie
Hradec Králové, Czechia
Fakultni Nemocnice Kralovske Vinohrady
Prague, Czechia
Fakultni Nemocnice V Motole
Prague, Czechia

Italy

Centro Di Riferimento Oncologico Di Aviano
Aviano, Italy
Instituto Di Ematologia Ed Oncologia Medica
Bologna, Italy
Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara
Pisa, Italy
Irccs Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy

Poland

Copernicus Podmiot Leczniczy Sp. Z O.O. Wojewodzkie Centrum Onkologii
Gdansk, Poland
Malopolskie Centrum Medyczne S.C.
Krakow, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych Z Warminsko-Mazurskim
Olsztyn, Poland

Spain

Hospital Universitario Vall D'Hebron
Barcelona, Spain
Hospital de la Santa Creu I Sant Paul
Barcelona, Spain
Institut Català D'Oncologia
L'Hospitalet de Llobregat, Spain
Complejo Hospitalano de Navarra Servicio Hematologia
Pamplona, Spain

United States

Arizona Oncology Associates, Pc - Hal
Phoenix, Arizona, United States
Arizona Oncology Associates, Pc - Hope
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
City of Hope National Medical Center
Duarte, California, United States
Sansum Clinic
Santa Barbara, California, United States
Stanford Cancer Center
Stanford, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Augusta University
Augusta, Georgia, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States
Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Johns Hopkins Medical Center
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Billings Clinic Cancer Research
Billings, Montana, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Summit Medical Group
Morristown, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
Mid Ohio Oncology/hematology Inc
Columbus, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States
Saint Francis Hospital / Bon Secours
Greenville, South Carolina, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States

11 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Brentuximab vedotin →Cyclophosphamide →Doxorubicin →Prednisone →Rituximab →Vincristine →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2013
Primary completion: 1 May 2017
Completion: 1 May 2017
Last update posted: 21 Jun 2018
Registered enrollment: 87
Registry id: NCT01925612

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.