Clinical trial NCT01925612: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma, B-cell
Lymphoma, Large B-cell, Diffuse
Keywords: Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Lymphoma, B-cell
Lymphoma, Large B-cell, Diffuse
Monomethyl auristatin E
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-20
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous history of treated indolent lymphoma
* History of another primary malignancy that has not been in remission for 3 years

Primary outcomes:
measure: Complete Remission Rate
timeFrame: Up to 6 months
measure: Incidence of Adverse Events
timeFrame: Up to 6 months
measure: Incidence of Laboratory Abnormalities
timeFrame: Up to 6 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Up to 6 months
measure: Progression-free Survival
timeFrame: Up to approximately 4 years
measure: Overall Survival
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Blood and Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists / Advocate Lutheran General Hospital
state: Illinois
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Cancer Research
state: Montana
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Morristown
country: United States
facility: Summit Medical Group
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Columbus
country: United States
facility: Mid Ohio Oncology/Hematology Inc
state: Ohio
city: Springfield
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Greenville
country: United States
facility: Saint Francis Hospital / Bon Secours
state: South Carolina
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Austin Midtown
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology - San Antonio Medical Center
state: Texas
city: The Woodlands
country: United States
facility: US Oncology Central Regulatory
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Seattle
country: United States
facility: Benaroya Research Institute/Virginia Mason Medical Center
state: Washington
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
city: Praha 10
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano
city: Bologna
country: Italy
facility: Instituto di Ematologia ed Oncologia Medica
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana - Ospedale S. Chiara
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Sofferenza
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Paul
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Català D'oncologia
city: Pamplona
country: Spain
facility: Complejo Hospitalano de Navarra Servicio Hematologia
Study officials:
affiliation: Seagen Inc.
name: Katherine Ruffner
role: STUDY_DIRECTOR
References: