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
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
2 other identifiers
interventional
206
1 country
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2009
Longer than P75 for phase_2
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
January 11, 2017
CompletedJanuary 11, 2017
November 1, 2016
5.8 years
July 1, 2009
August 11, 2016
November 14, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir.
Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Progression-Free Survival Rate
PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by \> 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years.
2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm)
Secondary Outcomes (8)
Overall Survival
Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Overall Response Rate (ORR)
End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Complete Response Rate
End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
Duration of Response
Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm
Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate
End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment]
- +3 more secondary outcomes
Study Arms (2)
RCHOP
ACTIVE COMPARATORRCHOP \[rituximab, cyclophosphamide, doxorubicin, prednisone\] 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.
Vc-RCHOP
EXPERIMENTALVc-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Tower Cancer Research Foundation
Beverly Hills, California, 90211, United States
Fountain Valley Regional Hospital
Fountain Valley, California, 92708, United States
St. Jude Heritage Healthcare
Fullerton, California, 92835, United States
Moores Cancer Center- UCSD
La Jolla, California, 92093, United States
Antelope Valley Cancer Center
Lancaster, California, 93534, United States
Loma Linda University Cancer Center
Loma Linda, California, 92354, United States
University of Southern California
Los Angeles, California, 90033, United States
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095, United States
TORI- Central Pharmacy
Los Angeles, California, United States
TORI- Central Regulatory
Los Angeles, California, United States
Oncology Care Medical Associates
Montebello, California, 90640, United States
Bay Area Cancer Research Group
Pleasant Hill, California, 94523, United States
Wilshire Oncology Medical Group
Rancho Cucamonga, California, 91730, United States
Sharp Healthcare
San Diego, California, 32123, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Florida Cancer Specialists
Fort Myers, Florida, 33619, United States
Florida Cancer Specialists & Research Institute
Gainsville, Florida, 32605, United States
Alves/ Domenech Oncology-Hematology Clinic
Hollywood, Florida, 33019, United States
Florida Cancer Institute ATI
New Port Richey, Florida, 34655, United States
MD Anderson Cancer Center of Orlando
Orlando, Florida, 32806, United States
Coastal Oncology, PL
Ormond Beach, Florida, 32174, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30341, United States
Dublin Hematology and Oncology
Dublin, Georgia, 31021, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Central Indiana Cancer Centers
Fishers, Indiana, 46227, United States
Cancer Care Center Inc. P.C.
New Albany, Indiana, 47150, United States
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, 52401, United States
Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
Siouxland Hematology and Oncology Associates LLP
Sioux City, Iowa, 51101, United States
Kansas City Cancer Center, LLC
Overland Park, Kansas, 66210, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
St. Agnes Hospital of Baltimore
Baltimore, Maryland, 21229, United States
Holy Cross Hospital
Silver Spring, Maryland, 20910, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805, United States
Berkshie Hematology Oncology
Pittsfield, Massachusetts, 01201, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mid Michigan Physicians
Lansing, Michigan, 48912, United States
Duluth Clinic
Duluth, Minnesota, 55805, United States
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, 55805, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Hematology/Oncology Associates of Northern New Jersey, P.A.
Morristown, New Jersey, 07962, United States
Hematology Oncology Associates of South Jersey
Mount Holly, New Jersey, 08060, United States
St. Luke's- Roosevelt Medical Center
New York, New York, 10019, United States
Cornell
New York, New York, United States
Raleigh Hematology Oncology Associates P.C.
Raleigh, North Carolina, 27607, United States
Summa Health System
Akron, Ohio, 44304, United States
Oncology Hematology Care
Cincinnati, Ohio, 45267, United States
Kaiser Group Health
Portland, Oregon, 97227, United States
Hematology and Oncology Associates of NEPA
Dunmore, Pennsylvania, 18512, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Guthrie Clinic
Sayre, Pennsylvania, 18840, United States
Berks Hematology Oncology Associates
West Reading, Pennsylvania, 19611, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29201, United States
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
US Oncology- Central Drug
Fort Worth, Texas, 76177, United States
US Oncology- Central Laboratory
Fort Worth, Texas, 76177, United States
Oncology Consultants P.A.
Houston, Texas, 77024, United States
Oncology Consultants
Houston, Texas, 77030, United States
US Oncology- Central Regulatory
The Woodlands, Texas, 77380, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Virginia Cancer Institute
Richmond, Virginia, 23230, United States
Puget Sound Cancer Centers
Edmonds, Washington, 98026, United States
Northwest Cancer Specialists PC
Vancover, Washington, 98686, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Monitor
Millennium Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2009
First Posted
July 2, 2009
Study Start
October 1, 2009
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
January 11, 2017
Results First Posted
January 11, 2017
Record last verified: 2016-11