Spots Global Cancer Trial Database for Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
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Trial Identification
Brief Title: Study of Brentuximab Vedotin Combined With RCHOP or RCHP in Front-line Treatment of Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Official Title: A Phase 2 Study of Brentuximab Vedotin in Combination With Standard of Care Treatment (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone [RCHOP]) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) as Front-line Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)
Study ID: NCT01925612
Study Description
Brief Summary: 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.
Detailed Description: In the first part of this study, patients in the 2 groups were tested to see if there was a difference in the response to treatment and whether there were differences in the side effects (unwanted effects). The second and third parts of the study are being done to see if there are any side effects (unwanted effects) of the higher dose of brentuximab vedotin when combined with a modified version of RCHOP that omits vincristine. The third part of the study is being done to see if there is a difference between BV+RCHP and RCHOP in the response to treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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, 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
Texas Oncology - Austin Midtown, Austin, Texas, United States
Texas Oncology - Baylor Sammons Cancer Center, Dallas, Texas, United States
US Oncology Investigational Products Center (IPC), Fort Worth, Texas, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Texas Oncology - San Antonio Medical Center, San Antonio, Texas, United States
US Oncology Central Regulatory, The Woodlands, Texas, United States
Texas Oncology - Tyler, Tyler, Texas, United States
University of Utah, Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
Benaroya Research Institute/Virginia Mason Medical Center, Seattle, Washington, United States
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie, Hradec Kralove, , Czechia
Fakultni Nemocnice Kralovske Vinohrady, Praha 10, , Czechia
Fakultni nemocnice v Motole, Praha 5, , Czechia
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
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
Hospital de la Santa Creu i Sant Paul, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Institut Català D'oncologia, L'Hospitalet de Llobregat, , Spain
Complejo Hospitalano de Navarra Servicio Hematologia, Pamplona, , Spain
Contact Details
Name: Katherine Ruffner
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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