Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study

Last updated: January 8, 2018
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Overall Status: Completed

Phase

3

Condition

Non-hodgkin's Lymphoma

Lymphoproliferative Disorders

Leukemia

Treatment

rituximab

doxorubicin

vincristine

Clinical Study ID

NCT00877006
C18083/3064/NL/MN
  • Ages > 18
  • All Genders

Study Summary

The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Histopathologic confirmation of one of the following cluster of differentiationantigen 20 positive (CD20+) B-cell non-Hodgkin's lymphomas (tissue diagnosticprocedures must be performed within 6 months of study entry and with biopsy materialavailable for review):

  • follicular lymphoma (NCI CTCAE grade 1 or 2)

  • immunoplasmacytoma/immunocytoma (Waldenstrom's macroglobulinemia)

  • splenic marginal zone B-cell lymphoma

  • extra-nodal marginal zone lymphoma of mucosa-associated lymphoid tumor (MALT)type

  • nodal marginal zone B-cell lymphoma

  • mantle cell lymphoma

  • Meets one of the following need-for-treatment criteria (with the exception of mantlecell lymphoma for which treatment is indicated):

  • presence of at least one of the following B-symptoms:

  1. fever (>38ºC) of unclear etiology

  2. night sweats

  3. weight loss of greater than 10% within the prior 6 months

  • large tumor mass (bulky disease)

  • presence of lymphoma-related complications, including narrowing of ureters orbile ducts, tumor-related compression of a vital organ, lymphoma-induced pain,cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, orascites

  • hyperviscosity syndrome due to monoclonal gammopathy

  • CD20+ B cells in lymph node biopsy or other lymphoma pathology specimen.

  • No prior treatment (patients on "watch and wait" may enter the study if a recentbiopsy [obtained within the last 6 months] is available)

  • Adequate hematologic function (unless abnormalities related to lymphoma infiltrationof the bone marrow or hypersplenism due to lymphoma) as follows:

  • hemoglobin of >= 10.0 g/dL

  • absolute neutrophil count (ANC) >=1.5*10^9/L

  • platelet count >=100*10^9/L

  • Bidimensionally measurable disease (field not previously radiated)

  • Able to provide written informed consent

  • Eastern Cooperative Oncology Group (ECOG) Performance Status <=2

  • Estimated life expectancy >=6 months

  • Serum creatinine of <=2.0 mg/dL or creatinine clearance >=50 mL/min

  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5*upper limit ofnormal (ULN), and alkaline phosphatase and total bilirubin within normal limits

  • Left ventricular ejection fraction (LVEF) >= 50% by multiple gated acquisition scan (MUGA) or cardiac echocardiogram (ECHO), prior for any patient to be treated withR-CHOP

  • A medically accepted method of contraception to be used by women of childbearingpotential (not surgically sterile or at least 12 months naturally postmenopausal)

  • Men capable of producing offspring and not surgically sterile must practice abstinenceor use a barrier method of birth control.

Exclusion

Key Exclusion Criteria:

  • Chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), or grade 3 follicularlymphoma

  • Transformed disease (bone marrow blasts are permitted; however, transformed diseaseindicating leukemic involvement is not permitted)

  • Central nervous system (CNS) lymphomatous involvement or leptomeningeal lymphoma

  • Prior radiation for NHL, except for a single course of locally delimited radiationtherapy with a radiation field not exceeding 2 adjacent lymph node regions

  • Active malignancy, other than NHL, within the past 3 years except for localizedprostate cancer treated with hormone therapy, cervical carcinoma in situ, breastcancer in situ, or non-melanoma skin cancer following definitive treatment

  • New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias orunstable angina, electrocardiograph (ECG) evidence of active ischemia or activeconduction system abnormalities, or myocardial infarction within the last 6 months (prior to study entry, ECG abnormalities at screening must be documented by theinvestigator as not medically relevant)

  • Known human immunodeficiency virus (HIV) positivity

  • Active hepatitis B or hepatitis C infection (hepatitis B surface antigen testingrequired)

  • Women who are pregnant or lactating

  • Corticosteroids for treatment of lymphoma within 28 days of study entry Chronicallyadministered low-dose corticosteroids (e.g., prednisone ≤20 mg/day) for indicationsother than lymphoma or lymphoma-related complications are permitted

  • Any serious uncontrolled, medical or psychological disorder that would impair theability of the patient to receive therapy

  • Any condition which places the patient at unacceptable risk or confounds the abilityof the investigators to interpret study data

  • Any other investigational agent within 28 days of study entry

  • Known hypersensitivity to bendamustine, mannitol, or other study-related drugs

  • Ann Arbor stage I disease.

Study Design

Total Participants: 447
Treatment Group(s): 6
Primary Treatment: rituximab
Phase: 3
Study Start date:
April 30, 2009
Estimated Completion Date:
March 31, 2012

Connect with a study center

  • St. Vincent's Hospital

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Cabrini Hospital Malvern

    Malvern, Victoria 3144
    Australia

    Site Not Available

  • Teva Investigational Site 315

    Perth, Western Australia
    Australia

    Site Not Available

  • Teva Investigational Site 305

    Concord,
    Australia

    Site Not Available

  • Teva Investigational Site 317

    Douglas,
    Australia

    Site Not Available

  • Teva Investigational Site 308

    East Melbourne,
    Australia

    Site Not Available

  • Teva Investigational Site 310

    Fitzroy,
    Australia

    Site Not Available

  • Teva Investigational Site 311

    Fitzroy,
    Australia

    Site Not Available

  • Teva Investigational Site 301

    Garran,
    Australia

    Site Not Available

  • Teva Investigational Site 316

    Geelong,
    Australia

    Site Not Available

  • Teva Investigational Site 304

    Hobart,
    Australia

    Site Not Available

  • Teva Investigational Site 312

    Kurralta Park,
    Australia

    Site Not Available

  • Teva Investigational Site 307

    Melbourne,
    Australia

    Site Not Available

  • Teva Investigational Site 306

    North Terrace,
    Australia

    Site Not Available

  • Teva Investigational Site 318

    Parkville,
    Australia

    Site Not Available

  • Teva Investigational Site 300

    South Brisbane,
    Australia

    Site Not Available

  • Westmead Hospital

    Sydney, NSW 2145
    Australia

    Site Not Available

  • Teva Investigational Site 303

    Westmead,
    Australia

    Site Not Available

  • Teva Investigational Site 314

    Wodonga,
    Australia

    Site Not Available

  • Teva Investigational Site 313

    Woodville,
    Australia

    Site Not Available

  • Teva Investigational Site 309

    Woolloongabba,
    Australia

    Site Not Available

  • Centro Goiano de Oncologia

    Goiania, GO 74075-040
    Brazil

    Site Not Available

  • Teva Investigational Site 503

    Barretos,
    Brazil

    Site Not Available

  • Fundacao Pio X11 - Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400
    Brazil

    Site Not Available

  • Teva Investigational Site 503

    Barretos-SP,
    Brazil

    Site Not Available

  • Teva Investigational Site 504

    Brasilia,
    Brazil

    Site Not Available

  • Teva Investigational Site 504

    Brasilia, DF,
    Brazil

    Site Not Available

  • Teva Investigational Site 506

    Curitiba,
    Brazil

    Site Not Available

  • Teva Investigational Site 505

    Goiania-GO,
    Brazil

    Site Not Available

  • Centro Goiano de Oncologia

    Goiânia - GO, 74075-040
    Brazil

    Site Not Available

  • Teva Investigational Site 505

    Goiânia,
    Brazil

    Site Not Available

  • Teva Investigational Site 502

    Jau,
    Brazil

    Site Not Available

  • Fundação Doutor Amaral Carvalho

    Jaú, 17210-120
    Brazil

    Site Not Available

  • Teva Investigational Site 509

    Lajeado,
    Brazil

    Site Not Available

  • Hospital Bruno Born

    Lajeado - RS, 95900-000
    Brazil

    Site Not Available

  • Teva Investigational Site 509

    Lajeado-RS,
    Brazil

    Site Not Available

  • Teva Investigational Site 507

    Porto Alegre,
    Brazil

    Site Not Available

  • Teva Investigational Site 508

    Porto Alegre,
    Brazil

    Site Not Available

  • Teva Investigational Site 511

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Teva Investigational Site 511

    Rio de Janeiro - RJ,
    Brazil

    Site Not Available

  • Teva Investigational Site 500

    Santo Andre,
    Brazil

    Site Not Available

  • Centro de Estudos da Disciplina de Hematologia da Faculdade de Medicina do ABC

    Santo André, 09060-650
    Brazil

    Site Not Available

  • Teva Investigational Site 501

    Sao Paulo,
    Brazil

    Site Not Available

  • Memorial University of Newfoundland

    St. John's, Newfoundland and Labrador A1B3V6
    Canada

    Site Not Available

  • Royal Victoria Hospital

    Montreal, Quebec H3A1A1
    Canada

    Site Not Available

  • Teva Investigational Site 202

    Barrie,
    Canada

    Site Not Available

  • Teva Investigational Site 206

    Calgary,
    Canada

    Site Not Available

  • Teva Investigational Site 200

    Halifax,
    Canada

    Site Not Available

  • Teva Investigational Site 201

    Ottawa,
    Canada

    Site Not Available

  • Teva Investigational Site 203

    Vancouver,
    Canada

    Site Not Available

  • Teva Investigational Site 204

    Winnipeg,
    Canada

    Site Not Available

  • Teva Investigational Site 602

    Aguascalientes,
    Mexico

    Site Not Available

  • Teva Investigational Site 603

    Hermosillo,
    Mexico

    Site Not Available

  • Teva Investigational Site 603

    Hermosillo, Sonora,
    Mexico

    Site Not Available

  • Teva Investigational Site 600

    Monterrey,
    Mexico

    Site Not Available

  • Teva Investigational Site 601

    Monterrey,
    Mexico

    Site Not Available

  • Teva Investigational Site 600

    Monterrey - NL,
    Mexico

    Site Not Available

  • Hospital General del Estado de Sonora

    Sonora, 83000
    Mexico

    Site Not Available

  • Teva Investigational Site 401

    Auckland,
    New Zealand

    Site Not Available

  • Teva Investigational Site 405

    Auckland,
    New Zealand

    Site Not Available

  • Teva Investigational Site 400

    Christchurch,
    New Zealand

    Site Not Available

  • Teva Investigational Site 402

    Newtown,
    New Zealand

    Site Not Available

  • Teva Investigational Site 404

    Palmerston North,
    New Zealand

    Site Not Available

  • Teva Investigational Site 403

    Takapuna,
    New Zealand

    Site Not Available

  • Wellington Hospital

    Wellington, 6021
    New Zealand

    Site Not Available

  • Teva Investigational Site 700

    Lima,
    Peru

    Site Not Available

  • Teva Investigational Site 701

    Lima,
    Peru

    Site Not Available

  • Teva Investigational Site 704

    Lima,
    Peru

    Site Not Available

  • Teva Investigational Site 702

    Miraflores,
    Peru

    Site Not Available

  • Teva Investigational Site 703

    Miraflores,
    Peru

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama
    United States

    Site Not Available

  • Teva Investigational Site 165

    Tucson, Arizona
    United States

    Site Not Available

  • Teva Investigational Site 167

    Little Rock, Arkansas
    United States

    Site Not Available

  • Tower Cancer Research Foundation

    Beverly Hills, California
    United States

    Site Not Available

  • Teva Investigational Site 11

    Corona, California
    United States

    Site Not Available

  • Teva Investigational Site 21

    Fountain Valley, California
    United States

    Site Not Available

  • Teva Investigational Site 52

    Fountain Valley, California
    United States

    Site Not Available

  • Teva Investigational Site 64

    Fullerton, California
    United States

    Site Not Available

  • Scripps Cancer Center

    LaJolla, California 92037
    United States

    Site Not Available

  • Teva Investigational Site 40

    Los Angeles, California
    United States

    Site Not Available

  • Teva Investigational Site 53

    Los Angeles, California
    United States

    Site Not Available

  • Comprehensive Cancer Center

    Palm Springs, California
    United States

    Site Not Available

  • Compassionate Cancer Care Medical Group, Inc.

    Riverside, California 92501
    United States

    Site Not Available

  • Teva Investigational Site 57

    San Diego, California
    United States

    Site Not Available

  • Teva Investigational Site 15

    Aurora, Colorado
    United States

    Site Not Available

  • University of Colorado

    Boulder, Colorado
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Teva Investigational Site 155

    Denver, Colorado
    United States

    Site Not Available

  • Teva Investigational Site 5

    Fort Collins, Colorado
    United States

    Site Not Available

  • Teva Investigational Site 70

    New Britain, Connecticut
    United States

    Site Not Available

  • Teva Investigational Site 37

    Norwalk, Connecticut
    United States

    Site Not Available

  • Teva Investigational Site 67

    Southington, Connecticut
    United States

    Site Not Available

  • Teva Investigational Site 58

    Fort Myers, Florida
    United States

    Site Not Available

  • Teva Investigational Site 38

    Hollywood, Florida
    United States

    Site Not Available

  • Teva Investigational Site 23

    Jacksonville, Florida
    United States

    Site Not Available

  • Teva Investigational Site 65

    Lake Worth, Florida
    United States

    Site Not Available

  • Teva Investigational Site 156

    Miami, Florida
    United States

    Site Not Available

  • Cancer Centers of Florida

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Teva Investigational Site 160

    Orlando, Florida
    United States

    Site Not Available

  • Teva Investigational Site 68

    Orlando, Florida
    United States

    Site Not Available

  • Teva Investigational Site 72

    Augusta, Georgia
    United States

    Site Not Available

  • Teva Investigational Site 50

    Columbus, Georgia
    United States

    Site Not Available

  • Teva Investigational Site 73

    Macon, Georgia
    United States

    Site Not Available

  • Teva Investigational Site 49

    Centralia, Illinois
    United States

    Site Not Available

  • Teva Investigational Site 48

    Chicago, Illinois
    United States

    Site Not Available

  • Teva Investigational Site 9

    Chicago, Illinois
    United States

    Site Not Available

  • Teva Investigational Site 14

    Normal, Illinois
    United States

    Site Not Available

  • Teva Investigational Site 24

    Beech Grove, Indiana
    United States

    Site Not Available

  • Teva Investigational Site 152

    Indianapolis, Indiana
    United States

    Site Not Available

  • Teva Investigational Site 31

    Iowa City, Iowa
    United States

    Site Not Available

  • Teva Investigational Site 63

    Waterloo, Iowa
    United States

    Site Not Available

  • Kansas City Cancer Center

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Teva Investigational Site 47

    Wichita, Kansas
    United States

    Site Not Available

  • Teva Investigational Site 33

    Lexington, Kentucky
    United States

    Site Not Available

  • Teva Investigational Site 19

    Shreveport, Louisiana
    United States

    Site Not Available

  • Teva Investigational Site 43

    Augusta, Maine
    United States

    Site Not Available

  • Massachusetts General Hospital, Harvard University

    Boston, Massachusetts
    United States

    Site Not Available

  • Teva Investigational Site 74

    Lowell, Massachusetts
    United States

    Site Not Available

  • Teva Investigational Site 22

    Duluth, Minnesota
    United States

    Site Not Available

  • Teva Investigational Site 4

    Saint Louis Park, Minnesota
    United States

    Site Not Available

  • Park Nicollet Institute

    St Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Teva Investigational Site 4

    St. Louis Park, Minnesota
    United States

    Site Not Available

  • Teva Investigational Site 162

    Columbia, Missouri
    United States

    Site Not Available

  • Teva Investigational Site 157

    Kansas City, Missouri
    United States

    Site Not Available

  • Teva Investigational Site 29

    Morristown, New Jersey
    United States

    Site Not Available

  • Teva Investigational Site 46

    Albuquerque, New Mexico
    United States

    Site Not Available

  • St. Vincent's Comprehensive Cancer Center

    New York, New York
    United States

    Site Not Available

  • Teva Investigational Site 8

    Rochester, New York
    United States

    Site Not Available

  • Teva Investigational Site 10

    Syracuse, New York
    United States

    Site Not Available

  • Teva Investigational Site 17

    Charlotte, North Carolina
    United States

    Site Not Available

  • Teva Investigational Site 151

    Durham, North Carolina
    United States

    Site Not Available

  • Teva Investigational Site 39

    Fargo, North Dakota
    United States

    Site Not Available

  • Teva Investigational Site 34

    Cincinnati, Ohio
    United States

    Site Not Available

  • Teva Investigational Site 60

    Cincinnati, Ohio
    United States

    Site Not Available

  • Teva Investigational Site 28

    Cleveland, Ohio
    United States

    Site Not Available

  • Providence Portland Medical Center

    Portland, Oregon
    United States

    Site Not Available

  • Teva Investigational Site 153

    Springfield, Oregon
    United States

    Site Not Available

  • Teva Investigational Site 59

    Bethlehem, Pennsylvania
    United States

    Site Not Available

  • Teva Investigational Site 44

    Danville, Pennsylvania
    United States

    Site Not Available

  • Teva Investigational Site 3

    Philadelphia, Pennsylvania
    United States

    Site Not Available

  • Teva Investigational Site 13

    Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Teva Investigational Site 7

    Pottstown, Pennsylvania
    United States

    Site Not Available

  • Teva Investigational Site 25

    Charleston, South Carolina
    United States

    Site Not Available

  • Teva Investigational Site 71

    Columbia, South Carolina
    United States

    Site Not Available

  • Teva Investigational Site 56

    Chattanooga, Tennessee
    United States

    Site Not Available

  • Teva Investigational Site 30

    Nashville, Tennessee
    United States

    Site Not Available

  • Teva Investigational Site 154

    Arlington, Texas
    United States

    Site Not Available

  • Teva Investigational Site 158

    Arlington, Texas
    United States

    Site Not Available

  • Teva Investigational Site 6

    El Paso, Texas
    United States

    Site Not Available

  • Teva Investigational Site 161

    Fort Worth, Texas
    United States

    Site Not Available

  • Teva Investigational Site 159

    San Antonio, Texas
    United States

    Site Not Available

  • Teva Investigational Site 166

    Sugar Land, Texas
    United States

    Site Not Available

  • Texas Oncology

    Tyler, Texas 75702
    United States

    Site Not Available

  • Teva Investigational Site 2

    Salt Lake City, Utah
    United States

    Site Not Available

  • Teva Investigational Site 18

    Abingdon, Virginia
    United States

    Site Not Available

  • Teva Investigational Site 35

    Charlottesville, Virginia
    United States

    Site Not Available

  • Teva Investigational Site 164

    Norfolk, Virginia
    United States

    Site Not Available

  • Cancer Outreach Asscociates, PC

    Richlands, Virginia
    United States

    Site Not Available

  • Teva Investigational Site 54

    Richmond, Virginia
    United States

    Site Not Available

  • Teva Investigational Site 42

    Seattle, Washington
    United States

    Site Not Available

  • Teva Investigational Site 150

    Spokane, Washington
    United States

    Site Not Available

  • Teva Investigational Site 163

    Vancouver, Washington
    United States

    Site Not Available

  • Teva Investigational Site 66

    Morgantown, West Virginia
    United States

    Site Not Available

  • Teva Investigational Site 41

    Madison, Wisconsin
    United States

    Site Not Available

  • Dean Foundation

    Middleton, Wisconsin
    United States

    Site Not Available

  • Teva Investigational Site 62

    Wausau, Wisconsin
    United States

    Site Not Available

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