Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL) Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 206 |
| Est. completion date | July 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Summa Health System | Akron | Ohio |
| United States | Georgia Cancer Specialists | Atlanta | Georgia |
| United States | Winship Cancer Institute at Emory University | Atlanta | Georgia |
| United States | Texas Oncology Cancer Center | Austin | Texas |
| United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
| United States | St. Agnes Hospital of Baltimore | Baltimore | Maryland |
| United States | Tower Cancer Research Foundation | Beverly Hills | California |
| United States | Lahey Clinic Medical Center | Burlington | Massachusetts |
| United States | Iowa Blood and Cancer Care | Cedar Rapids | Iowa |
| United States | Chattanooga Oncology and Hematology Associates, PC | Chattanooga | Tennessee |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Oncology Hematology Care | Cincinnati | Ohio |
| United States | Missouri Cancer Associates | Columbia | Missouri |
| United States | South Carolina Oncology Associates, PA | Columbia | South Carolina |
| United States | Rocky Mountain Cancer Center | Denver | Colorado |
| United States | Iowa Oncology Research Association | Des Moines | Iowa |
| United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
| United States | Dublin Hematology and Oncology | Dublin | Georgia |
| United States | Duluth Clinic | Duluth | Minnesota |
| United States | St. Luke's Hospital Cancer Care Center | Duluth | Minnesota |
| United States | Hematology and Oncology Associates of NEPA | Dunmore | Pennsylvania |
| United States | Puget Sound Cancer Centers | Edmonds | Washington |
| United States | Central Indiana Cancer Centers | Fishers | Indiana |
| United States | Florida Cancer Specialists | Fort Myers | Florida |
| United States | US Oncology- Central Drug | Fort Worth | Texas |
| United States | US Oncology- Central Laboratory | Fort Worth | Texas |
| United States | Fountain Valley Regional Hospital | Fountain Valley | California |
| United States | St. Jude Heritage Healthcare | Fullerton | California |
| United States | Florida Cancer Specialists & Research Institute | Gainsville | Florida |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Alves/ Domenech Oncology-Hematology Clinic | Hollywood | Florida |
| United States | Oncology Consultants | Houston | Texas |
| United States | Oncology Consultants P.A. | Houston | Texas |
| United States | Saint Luke's Cancer Institute | Kansas City | Missouri |
| United States | Moores Cancer Center- UCSD | La Jolla | California |
| United States | Antelope Valley Cancer Center | Lancaster | California |
| United States | Mid Michigan Physicians | Lansing | Michigan |
| United States | Loma Linda University Cancer Center | Loma Linda | California |
| United States | Jonsson Comprehensive Cancer Center | Los Angeles | California |
| United States | TORI- Central Pharmacy | Los Angeles | California |
| United States | TORI- Central Regulatory | Los Angeles | California |
| United States | University of Southern California | Los Angeles | California |
| United States | Oncology Care Medical Associates | Montebello | California |
| United States | Hematology/Oncology Associates of Northern New Jersey, P.A. | Morristown | New Jersey |
| United States | Hematology Oncology Associates of South Jersey | Mount Holly | New Jersey |
| United States | Tennessee Oncology | Nashville | Tennessee |
| United States | Cancer Care Center Inc. P.C. | New Albany | Indiana |
| United States | Florida Cancer Institute ATI | New Port Richey | Florida |
| United States | Cornell | New York | New York |
| United States | St. Luke's- Roosevelt Medical Center | New York | New York |
| United States | MD Anderson Cancer Center of Orlando | Orlando | Florida |
| United States | Coastal Oncology, PL | Ormond Beach | Florida |
| United States | Kansas City Cancer Center, LLC | Overland Park | Kansas |
| United States | UPMC Cancer Center | Pittsburgh | Pennsylvania |
| United States | Berkshie Hematology Oncology | Pittsfield | Massachusetts |
| United States | Bay Area Cancer Research Group | Pleasant Hill | California |
| United States | Kaiser Group Health | Portland | Oregon |
| United States | Raleigh Hematology Oncology Associates P.C. | Raleigh | North Carolina |
| United States | Wilshire Oncology Medical Group | Rancho Cucamonga | California |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | Sharp Healthcare | San Diego | California |
| United States | Central Coast Medical Oncology Corporation | Santa Maria | California |
| United States | Guthrie Clinic | Sayre | Pennsylvania |
| United States | Holy Cross Hospital | Silver Spring | Maryland |
| United States | Siouxland Hematology and Oncology Associates LLP | Sioux City | Iowa |
| United States | US Oncology- Central Regulatory | The Woodlands | Texas |
| United States | Tyler Cancer Center | Tyler | Texas |
| United States | Northwest Cancer Specialists PC | Vancover | Washington |
| United States | Berks Hematology Oncology Associates | W Reading | Pennsylvania |
| United States | Texoma Cancer Center | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Millennium Pharmaceuticals, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL). | 48 months | No | |
| Secondary | Overall Survival | 48 months | No | |
| Secondary | Overall Response Rate, Complete Response Rate and Duration of Response | 48 months | No | |
| Secondary | Fluorodeoxyglucose positron emission tomography (FDG-PET) negative rate | 48 months | No | |
| Secondary | Time to Progression | 48 months | No | |
| Secondary | Safety of the drug combination of VELCADE with RCHOP (Vc-RCHOP) | 48 months | Yes |