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



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/23/2018
Start Date:August 2013
End Date:May 1, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

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)

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.

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.

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
We found this trial at
37
sites
University of Arkansas for Medical Sciences
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Pooja Motwani
Phone: 501-686-8274
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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Johns Hopkins Medical Center
Baltimore, Maryland 21231
Principal Investigator: Nina Wagner-Johnston, MD
Phone: 410-955-8839
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Baltimore, MD
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University of Utah
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Ahmad Halwani, MD
Phone: 801-213-5720
University of Utah Research is a major component in the life of the U benefiting...
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New York Oncology Hematology PC
Albany, New York 12206
Principal Investigator: Lawrence Garbo, MD
Phone: 281-863-6658
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Augusta University
Augusta, Georgia 30912
Principal Investigator: Locke Bryan, MD
Phone: 706-721-0730
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Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado 80012
Principal Investigator: John Burke, MD
Phone: 281-863-6658
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Texas Oncology - Austin Midtown
Austin, Texas 78705
Principal Investigator: Jason Melear, MD
Phone: 281-863-6658
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Austin, TX
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Comprehensive Blood and Cancer Center
Bakersfield, California 93309
Principal Investigator: Alan Cartmell, MD
Phone: 661-862-7122
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Billings Clinic Cancer Research
Billings, Montana 59101
Principal Investigator: Brock Whittenberger, MD
Phone: 406-435-7481
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Fakultni nemocnice Brno
Brno, 62500
Principal Investigator: Jiri Mayer, MD
Phone: 866-333-7436
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Mid Ohio Oncology Hematology, Inc.
Columbus, Ohio
Principal Investigator: Mark Knapp, MD
Phone: 614-383-6236
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Texas Oncology - Baylor Sammons Cancer Center
Dallas, Texas 75246
Principal Investigator: Moshe Levy, MD
Phone: 281-863-6658
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Henry Ford Health System
Detroit, Michigan 48202
Principal Investigator: Philip Kuriakose, MD
Phone: 313-916-7827
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Detroit, MI
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City of Hope National Medical Center
1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
Principal Investigator: Lihua Elizabeth Budde, MD
Phone: 626-218-3033
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Virginia Cancer Specialists, PC
8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Principal Investigator: Dipti Patel-Donnelly, MD
Phone: 281-863-6658
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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US Oncology Investigational Products Center (IPC)
Fort Worth, Texas 76177
Principal Investigator: Christopher Yasenchak
Phone: 866-333-7436
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Saint Francis Hospital / Bon Secours
Greenville, South Carolina 29601
Principal Investigator: Howland Crosswell
Phone: 864-603-6212
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M.D. Anderson Cancer Center at University of Texas
Houston, Texas 77030
Principal Investigator: Luis Fayad, MD
Phone: 713-563-1429
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Tennessee Cancer Specialists
Knoxville, Tennessee 37920
Principal Investigator: Tracy Dobbs, MD
Phone: 865-934-2673
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Comprehensive Cancer Centers of Nevada
9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Edwin Kingsley, MD
Phone: 281-863-6658
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Norton Cancer Institute
Louisville, Kentucky 40207
Principal Investigator: Don Stevens, MD
Phone: 502-899-3366
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Cardinal Bernardin Cancer Center at Loyola University Medical Center
2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Principal Investigator: Scott Smith, MD
Phone: 708-327-3228
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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Summit Medical Group
Morristown, New Jersey 07960
Principal Investigator: Charles Farber
Phone: 973-436-1755
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Jersey Shore University Medical Center
Neptune, New Jersey 07754
Principal Investigator: William Lerner, MD
Phone: 732-776-3466
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Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles, Illinois 60714
Principal Investigator: Leonard Klein, MD
Phone: 281-863-6658
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Arizona Oncology Associates, PC - HAL
Phoenix, Arizona 85016
Principal Investigator: Mahesh Seetharam, MD
Phone: 281-863-6658
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VCU Medical Center
1250 E. Marshall St.
Richmond, Virginia 23298
(804) 828-9000
Principal Investigator: Beata Holkova, MD
Phone: 804-628-1909
Virginia Commonwealth University Medical Center The Virginia Commonwealth University Health System is an urban, comprehensive...
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Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Texas Oncology - San Antonio Medical Center
San Antonio, Texas 78229
Principal Investigator: Roger Lyons, M.D.
Phone: 281-863-6658
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Sansum Clinic
Santa Barbara, California 93105
Principal Investigator: Daniel Greenwald, MD
Phone: 281-863-6658
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Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington 98101
Principal Investigator: David Aboulafia
Phone: 206-342-6500
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Willamette Valley Cancer Institute and Research Center
Springfield, Oregon 97477
Principal Investigator: Christopher Yasenchak, MD
Phone: 281-863-6658
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Stanford Cancer Center
Stanford, California 94305
Principal Investigator: Ranjana Advani, MD
Phone: 650-736-2563
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US Oncology- Central Regulatory
The Woodlands, Texas 77380
Principal Investigator: Christopher Yasenchak
Phone: 866-333-7436
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Northwest Cancer Specialists, PC
Tualatin, Oregon 97062
Principal Investigator: Kathryn Kolibaba, MD
Phone: 281-863-6658
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Arizona Oncology Associates, PC - HOPE
Tucson, Arizona 85704
Principal Investigator: Donald Brooks, MD
Phone: 281-863-6658
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Texas Oncology-Tyler
Tyler, Texas 75702
Principal Investigator: Habte Yimer, MD
Phone: 281-863-6658
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