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 |
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.
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.
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
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166 Stoneridge Drive
Columbia, South Carolina 29210
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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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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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
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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1365 Clifton Rd NE
Atlanta, Georgia 30322
Atlanta, Georgia 30322
(404) 778-1900
Winship Cancer Institute at Emory University Winship Cancer Institute of Emory University is Georgia
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Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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4321 Washington Street #4000
Kansas City, Missouri 64111
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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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
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