Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2009
End Date:July 2015

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An Open-Label, Randomized, Phase 2 Study to Assess the Effectiveness of RCHOP With or Without VELCADE in Previously Untreated Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma Patients

This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without
VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse
Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to
RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.

This study will be recruiting patients in Utah, Texas, Florida, Illinois, New Jersey and
Michigan. Please call 1-866-835-2233 for more information.

Each patient must meet all of the following inclusion criteria to be enrolled in the
study:

Inclusion Criteria:

- Patients with previously untreated DLBCL that has been sub classified as the non-GCB
subtype.

- At least 1 measurable tumor mass.

- Availability of paraffin block with sufficient tumor tissue.

- No evidence of central nervous system lymphoma.

- Eastern Cooperative Oncology Group (ECOG) performance status of < or equal to 2.

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception or abstain from heterosexual intercourse.

- Male patients who agree to practice effective barrier contraception or agree to
abstain from heterosexual intercourse.

Patients meeting any of the following exclusion criteria are not to be enrolled in the
study:

Exclusion Criteria:

- Diagnosed or treated for a malignancy other than DLBCL within 2 years of first dose
or evidence of active malignancy other than DLBCL.

- Peripheral neuropathy of Grade 2 or greater.

- Known history of human immunodeficiency virus (HIV) infection, unless receiving
highly active antiretroviral therapy (HAART).

- Active infection requiring systemic therapy.

- Major surgery within 2 weeks before first dose.

- Patients with a left ventricular ejection fraction (LVEF) or less than 45%.

- Myocardial infarction with 6 months of enrollment or evidence of current uncontrolled
cardiovascular conditions as described in the protocol.

- History of allergic reaction/ hypersensitivity attributable to boron, mannitol,
polysorbate 80 or sodium citrate dehydrate, or anaphylaxis or immunoglobulin E
(IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab.
We found this trial at
69
sites
Burlington, Massachusetts 01805
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166 Stoneridge Drive
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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1400 South Orange Avenue
Orlando, Florida 32806
(407) 648-3800
M.D. Anderson Cancer Center at Orlando For more than twenty years, our cancer center has...
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220 S Palisade Dr # 204
Santa Maria, California 93454
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Akron, Ohio 44304
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1365 Clifton Rd NE
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Atlanta, Georgia 30341
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Austin, Texas 78731
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Baltimore, Maryland 21229
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Beverly Hills, California 90211
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Cedar Rapids, Iowa 52402
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Chattanooga, Tennessee 37404
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Columbia, Missouri 65201
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Denver, Colorado 80218
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Des Moines, Iowa 50309
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Dublin, Georgia 31021
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Duluth, Minnesota 55805
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Duluth, Minnesota 55805
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Dunmore, Pennsylvania 18512
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Edmonds, Washington 98026
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Fishers, Indiana 46037
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Fort Worth, Texas 76177
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Fort Worth, Texas 76177
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Fountain Valley, California 92708
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Fullerton, California 92835
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Houston, Texas 77203
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4321 Washington Street #4000
Kansas City, Missouri 64111
(816) 932-3300
Saint Luke's Cancer Institute Hope is an important part of the arsenal that helps patients...
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La Jolla, California 92093
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Lancaster, California 93534
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Lansing, Michigan 48912
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Loma Linda, California 92354
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Los Angeles, California 90095
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Los Angeles, California
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Los Angeles, California
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Montebello, California 90640
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Mount Holly, New Jersey 08060
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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New Albany, Indiana 47150
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New Port Richey, Florida 34655
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New York, New York 10019
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New York, New York
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Ormond Beach, Florida 32174
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Overland Park, Kansas 66210
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Pittsburgh, Pennsylvania 15232
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Pittsfield, Massachusetts 01201
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Pleasant Hill, California 94523
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Portland, Oregon 97227
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Raleigh, North Carolina 27607
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Rancho Cucamonga, California 91730
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Richmond, Virginia 23235
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San Diego, California 32123
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Sayre, Pennsylvania 18840
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Silver Spring, Maryland 20910
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230 Nebraska St.
Sioux City, Iowa 51101
712-252-0088
Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
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The Woodlands, Texas 77380
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Tyler, Texas 75702
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Vancover, Washington 98686
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W Reading, Pennsylvania 19611
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Wichita Falls, Texas 76310
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