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

NCT ID: NCT00931918

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-08-31

Brief Summary

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.

Detailed Description

The drug tested in this study is called bortezomib (VELCADE®). VELCADE® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy of RCHOP [rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone] with or without VELCADE®.

The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups:

• RCHOP
• Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone]

Participants received treatment for up to six, 21-day cycles.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.

Conditions

Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RCHOP

RCHOP \[rituximab, cyclophosphamide, doxorubicin, prednisone\] administered as follows: rituximab 375 mg/m\^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m\^2 IV infusion, doxorubicin 50 mg/m\^2 IV injection and vincristine 1.4 mg/m\^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.

Group Type: ACTIVE_COMPARATOR

Rituximab

Intervention Type: DRUG

Rituximab IV

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide IV

Doxorubicin

Intervention Type: DRUG

Doxorubicin IV solution

Vincristine

Intervention Type: DRUG

Vincristine IV

Prednisone

Intervention Type: DRUG

Prednisone tablet

Vc-RCHOP

Vc-RCHOP \[bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone\] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m\^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m\^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m\^2 IV infusion, doxorubicin 50 mg/m\^2 IV injection and vincristine 1.4 mg/m\^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib IV

Rituximab

Intervention Type: DRUG

Rituximab IV

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide IV

Doxorubicin

Intervention Type: DRUG

Doxorubicin IV solution

Vincristine

Intervention Type: DRUG

Vincristine IV

Prednisone

Intervention Type: DRUG

Prednisone tablet

Interventions

Bortezomib

Bortezomib IV

Intervention Type: DRUG

Rituximab

Rituximab IV

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide IV

Intervention Type: DRUG

Doxorubicin

Doxorubicin IV solution

Intervention Type: DRUG

Vincristine

Vincristine IV

Intervention Type: DRUG

Prednisone

Prednisone tablet

Intervention Type: DRUG

Other Intervention Names

VELCADE®

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Tower Cancer Research Foundation

Beverly Hills, California, United States

Fountain Valley Regional Hospital

Fountain Valley, California, United States

St. Jude Heritage Healthcare

Fullerton, California, United States

Moores Cancer Center- UCSD

La Jolla, California, United States

Antelope Valley Cancer Center

Lancaster, California, United States

Loma Linda University Cancer Center

Loma Linda, California, United States

University of Southern California

Los Angeles, 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

Oncology Care Medical Associates

Montebello, California, United States

Bay Area Cancer Research Group

Pleasant Hill, California, United States

Wilshire Oncology Medical Group

Rancho Cucamonga, California, United States

Sharp Healthcare

San Diego, California, United States

Central Coast Medical Oncology Corporation

Santa Maria, California, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Florida Cancer Specialists & Research Institute

Gainsville, Florida, United States

Alves/ Domenech Oncology-Hematology Clinic

Hollywood, Florida, United States

Florida Cancer Institute ATI

New Port Richey, Florida, United States

MD Anderson Cancer Center of Orlando

Orlando, Florida, United States

Coastal Oncology, PL

Ormond Beach, Florida, United States

Winship Cancer Institute at Emory University

Atlanta, Georgia, United States

Georgia Cancer Specialists

Atlanta, Georgia, United States

Dublin Hematology and Oncology

Dublin, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Central Indiana Cancer Centers

Fishers, Indiana, United States

Cancer Care Center Inc. P.C.

New Albany, Indiana, United States

Iowa Blood and Cancer Care

Cedar Rapids, Iowa, United States

Iowa Oncology Research Association

Des Moines, Iowa, United States

Siouxland Hematology and Oncology Associates LLP

Sioux City, Iowa, United States

Kansas City Cancer Center, LLC

Overland Park, Kansas, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

St. Agnes Hospital of Baltimore

Baltimore, Maryland, United States

Holy Cross Hospital

Silver Spring, Maryland, United States

Lahey Clinic Medical Center

Burlington, Massachusetts, United States

Berkshie Hematology Oncology

Pittsfield, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Mid Michigan Physicians

Lansing, Michigan, United States

Duluth Clinic

Duluth, Minnesota, United States

St. Luke's Hospital Cancer Care Center

Duluth, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, 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

St. Luke's- Roosevelt Medical Center

New York, New York, United States

Cornell

New York, New York, United States

Raleigh Hematology Oncology Associates P.C.

Raleigh, North Carolina, United States

Summa Health System

Akron, Ohio, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Kaiser Group Health

Portland, Oregon, United States

Hematology and Oncology Associates of NEPA

Dunmore, Pennsylvania, United States

UPMC Cancer Center

Pittsburgh, Pennsylvania, United States

Guthrie Clinic

Sayre, Pennsylvania, United States

Berks Hematology Oncology Associates

West Reading, Pennsylvania, United States

South Carolina Oncology Associates, PA

Columbia, South Carolina, United States

Chattanooga Oncology and Hematology Associates, PC

Chattanooga, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology Cancer Center

Austin, Texas, United States

US Oncology- Central Drug

Fort Worth, Texas, United States

US Oncology- Central Laboratory

Fort Worth, Texas, United States

Oncology Consultants P.A.

Houston, Texas, United States

Oncology Consultants

Houston, Texas, United States

US Oncology- Central Regulatory

The Woodlands, Texas, United States

Tyler Cancer Center

Tyler, Texas, United States

Texoma Cancer Center

Wichita Falls, Texas, United States

Virginia Cancer Institute

Richmond, Virginia, United States

Puget Sound Cancer Centers

Edmonds, Washington, United States

Northwest Cancer Specialists PC

Vancover, Washington, United States

Countries

United States

Other Identifiers

U1111-1183-0186

Identifier Type: REGISTRY

Identifier Source: secondary_id

C05013

Identifier Type: -

Identifier Source: org_study_id