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)

Status: Terminated
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b

• International Prognostic Index (IPI) score greater than or equal to 3 for patients greater than 60 years of age or age-adjusted IPI (aaIPI) score of 2 or 3 for patients less than or equal to 60 years of age

• Stage IAX (bulk defined as single lymph node mass \>10 cm in diameter), IB-IV disease

• Measurable disease of at least 1.5 cm

• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

• Patients in Parts 2 and 3 must have histologically confirmed diagnosis of CD30-positive DLBCL

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Arizona
Arizona Oncology Associates, PC - HAL
Phoenix
Arizona Oncology Associates, PC - HOPE
Tucson
California
Comprehensive Blood and Cancer Center
Bakersfield
City of Hope National Medical Center
Duarte
Sansum Clinic
Santa Barbara
Stanford Cancer Center
Stanford
Colorado
Rocky Mountain Cancer Centers - Aurora
Aurora
Georgia
Augusta University
Augusta
Illinois
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood
Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles
Kentucky
Norton Cancer Institute
Louisville
Maryland
Johns Hopkins Medical Center
Baltimore
Michigan
Henry Ford Health System
Detroit
Missouri
Washington University School of Medicine
Saint Louis
Montana
Billings Clinic Cancer Research
Billings
New Jersey
Summit Medical Group
Morristown
Jersey Shore University Medical Center
Neptune
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
New York Oncology Hematology, P.C.
Albany
Ohio
Mid Ohio Oncology/Hematology Inc
Columbus
Oregon
Willamette Valley Cancer Institute and Research Center
Springfield
Northwest Cancer Specialists, P.C.
Tualatin
South Carolina
Saint Francis Hospital / Bon Secours
Greenville
Tennessee
Tennessee Cancer Specialists
Knoxville
Texas
Texas Oncology - Austin Midtown
Austin
Texas Oncology - Baylor Sammons Cancer Center
Dallas
US Oncology Investigational Products Center (IPC)
Fort Worth
MD Anderson Cancer Center / University of Texas
Houston
Texas Oncology - San Antonio Medical Center
San Antonio
US Oncology Central Regulatory
The Woodlands
Texas Oncology - Tyler
Tyler
Utah
University of Utah
Salt Lake City
Virginia
Virginia Cancer Specialists, PC
Fairfax
Virginia Commonwealth University Medical Center
Richmond
Washington
Benaroya Research Institute/Virginia Mason Medical Center
Seattle
Other Locations
Italy
Centro di Riferimento Oncologico di Aviano
Aviano
Instituto di Ematologia ed Oncologia Medica
Bologna
Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara
Pisa
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo
Poland
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk
Malopolskie Centrum Medyczne S.C.
Krakow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
Olsztyn
Spain
Hospital de la Santa Creu i Sant Paul
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Institut Català D'oncologia
L'hospitalet De Llobregat
Complejo Hospitalano de Navarra Servicio Hematologia
Pamplona
Time Frame
Start Date: 2013-08
Completion Date: 2017-05-01
Participants
Target number of participants: 87
Treatments
Experimental: Part 1: BV(1.2 mg/kg) + RCHOP
Brentuximab vedotin 1.2 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone~Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.2 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.
Experimental: Part 1: BV(1.8 mg/kg) + RCHOP
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone~Part 1 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin when administered in combination with standard RCHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). Patients in this arm were randomized into the 1.8 mg/kg brentuximab vedotin dosing cohort, to be administered in combination with RCHOP.
Experimental: Part 2: BV(1.8 mg/kg) + RCHP
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone~Part 2 of the study is a phase 2, non-randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone). Patients in this treatment arm were enrolled into a dosing cohort with 1.8 mg/kg brentuximab vedotin administered in combination with RCHP.
Active_comparator: Part 3: RCHOP
Rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone~Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone.
Experimental: Part 3: BV(1.8 mg/kg) + RCHP
Brentuximab vedotin 1.8 mg/kg plus rituximab, cyclophosphamide, doxorubicin, prednisone~Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive RCHOP treatment alone. Randomization in this part of the study is for the purpose of evaluating the safety of 1.8 mg/kg brentuximab vedotin in combination with RCHP versus standard RCHOP chemotherapy.~Part 3 of the study is a phase 2, randomized, open-label, multicenter study designed to evaluate the antitumor activity and safety of brentuximab vedotin 1.8 mg/kg when administered in combination with RCHP chemotherapy compared to RCHOP chemotherapy alone. Patients in this treatment arm were randomized to receive 1.8 mg/kg brentuximab vedotin administered in combination with RCHP.
Sponsors
Leads: Seagen Inc.

This content was sourced from clinicaltrials.gov

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