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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)

Thank you

Trial Information

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 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

48 months

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C05013

NCT ID:

NCT00931918

Start Date:

October 2009

Completion Date:

September 2015

Related Keywords:

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

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Rush University Medical CenterChicago, Illinois  60612-3824
Hackensack University Medical CenterHackensack, New Jersey  07601
Summa Health SystemAkron, Ohio  44312
Duluth ClinicDuluth, Minnesota  55805
Rocky Mountain Cancer CenterDenver, Colorado  80218
Georgia Cancer SpecialistsDecatur, Georgia  30033
Florida Cancer SpecialistsFort Myers, Florida  33901
Oncology ConsultantsHouston, Texas  77024
Missouri Cancer AssociatesColumbia, Missouri  65201
St. Luke's Hospital Cancer Care CenterDuluth, Minnesota  55805
Tyler Cancer CenterTyler, Texas  75702
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
Iowa Blood and Cancer CareCedar Rapids, Iowa  52402
Tower Cancer Research FoundationBeverly Hills, California  90211
Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Sharp HealthcareSan Diego, California  92121
Virginia Cancer InstituteRichmond, Virginia  23230
Wilshire Oncology Medical GroupGlendora, California  91741
Bay Area Cancer Research GroupConcord, California  94520
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Texoma Cancer CenterWichita Falls, Texas  76310
Winship Cancer Institute at Emory UniversityAtlanta, Georgia  30322
Holy Cross HospitalSilver Spring, Maryland  20910
University of Southern CaliforniaLos Angeles, California  90033
Texas Oncology Cancer CenterAustin, Texas  78731
Saint Luke's Cancer InstituteKansas City, Missouri  64111
Guthrie ClinicSayre, Pennsylvania  18840
Puget Sound Cancer CentersEdmonds, Washington  98026
Oncology Care Medical AssociatesMontebello, California  90640
Antelope Valley Cancer CenterLancaster, California  93534
Oncology Consultants P.A.Houston, Texas  77024
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Loma Linda University Cancer CenterLoma Linda, California  92354
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
Tennessee OncologyNashville, Tennessee  37203
Oncology Hematology CareCincinnati, Ohio  45242
Berks Hematology Oncology AssociatesWest Reading, Pennsylvania  19611
MD Anderson Cancer Center of OrlandoOrlando, Florida  32806
Kansas City Cancer Center, LLCOverland Park, Kansas  66210
Dublin Hematology and OncologyDublin, Georgia  31021
St. Jude Heritage HealthcareFullerton, California  92835
Kaiser Group HealthPortland, Oregon  97227
Hematology and Oncology Associates of NEPAScranton, Pennsylvania  18501
Fountain Valley Regional HospitalFountain Valley, California  92708
Moores Cancer Center- UCSDLa Jolla, California  92093
Jonsson Comprehensive Cancer CenterLos Angeles, California  90095
TORI- Central RegulatoryLos Angeles, California  
TORI- Central PharmacyLos Angeles, California  
Florida Cancer Specialists & Research InstituteGainsville, Florida  32605
Alves/ Domenech Oncology-Hematology ClinicHollywood, Florida  33019
Florida Cancer Institute ATINew Port Richey, Florida  34655
Coastal Oncology, PLOrmond Beach, Florida  32174
Cancer Care Center Inc. P.C.New Albany, Indiana  47150
Siouxland Hematology and Oncology Associates LLPSioux City, Iowa  51101
St. Agnes Hospital of BaltimoreBaltimore, Maryland  21229
Berkshie Hematology OncologyPittsfield, Massachusetts  01201
Mid Michigan PhysiciansLansing, Michigan  48912
Hematology/Oncology Associates of Northern New Jersey, P.A.Morristown, New Jersey  07962
Hematology Oncology Associates of South JerseyMount Holly, New Jersey  08060
St. Luke's- Roosevelt Medical CenterNew York, New York  10019
CornellNew York, New York  
Raleigh Hematology Oncology Associates P.C.Raleigh, North Carolina  27607
UPMC Cancer CenterPittsburgh, Pennsylvania  15232
Chattanooga Oncology and Hematology Associates, PCChattanooga, Tennessee  37404
US Oncology- Central LaboratoryFort Worth, Texas  76177
US Oncology- Central DrugFort Worth, Texas  76177
US Oncology- Central RegulatoryThe Woodlands, Texas  77380
Northwest Cancer Specialists PCVancover, Washington  98686