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
NCT ID: NCT00877006
Last Updated: 2018-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
447 participants
INTERVENTIONAL
2009-04-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bendamustine and Rituximab (BR)
Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\^2 IV on Day 1
bendamustine
rituximab
R-CHOP/R-CVP
Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.
R-CHOP: rituximab 375 mg/m\^2 IV on Day 1; vincristine 1.4 mg/m\^2 (up to 2 mg/m\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\^2 IV Day 1; cyclophosphamide 750 mg/m\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5
R-CVP: rituximab 375 mg/m\^2 IV on Day 1; cyclophosphamide 750 mg/m\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\^2 IV on Day 1; vincristine 1.4 mg/m\^2 (up to 2 mg/m\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5
rituximab
vincristine
prednisone
cyclophosphamide
doxorubicin
Interventions
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bendamustine
rituximab
vincristine
prednisone
cyclophosphamide
doxorubicin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 mantle cell 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 or bile ducts, tumor-related compression of a vital organ, lymphoma-induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites
* 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 recent biopsy \[obtained within the last 6 months\] is available)
* Adequate hematologic function (unless abnormalities related to lymphoma infiltration of 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 of normal (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 with R-CHOP
* A medically accepted method of contraception to be used by women of childbearing potential (not surgically sterile or at least 12 months naturally postmenopausal)
* Men capable of producing offspring and not surgically sterile must practice abstinence or use a barrier method of birth control.
Exclusion Criteria
* Transformed disease (bone marrow blasts are permitted; however, transformed disease indicating 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 radiation therapy with a radiation field not exceeding 2 adjacent lymph node regions
* Active malignancy, other than NHL, within the past 3 years except for localized prostate cancer treated with hormone therapy, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer following definitive treatment
* New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias or unstable angina, electrocardiograph (ECG) evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months (prior to study entry, ECG abnormalities at screening must be documented by the investigator as not medically relevant)
* Known human immunodeficiency virus (HIV) positivity
* Active hepatitis B or hepatitis C infection (hepatitis B surface antigen testing required)
* Women who are pregnant or lactating
* Corticosteroids for treatment of lymphoma within 28 days of study entry Chronically administered low-dose corticosteroids (e.g., prednisone ≤20 mg/day) for indications other than lymphoma or lymphoma-related complications are permitted
* Any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to receive therapy
* Any condition which places the patient at unacceptable risk or confounds the ability of 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.
18 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sponsor's Medical Expert
Role: STUDY_DIRECTOR
Cephalon
Locations
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Teva Investigational Site 165
Tucson, Arizona, United States
Teva Investigational Site 167
Little Rock, Arkansas, United States
Teva Investigational Site 11
Corona, California, United States
Teva Investigational Site 21
Fountain Valley, California, United States
Teva Investigational Site 52
Fountain Valley, California, United States
Teva Investigational Site 64
Fullerton, California, United States
Teva Investigational Site 40
Los Angeles, California, United States
Teva Investigational Site 53
Los Angeles, California, United States
Teva Investigational Site 57
San Diego, California, United States
Teva Investigational Site 15
Aurora, Colorado, United States
Teva Investigational Site 155
Denver, Colorado, United States
Teva Investigational Site 5
Fort Collins, Colorado, United States
Teva Investigational Site 70
New Britain, Connecticut, United States
Teva Investigational Site 37
Norwalk, Connecticut, United States
Teva Investigational Site 67
Southington, Connecticut, United States
Teva Investigational Site 58
Fort Myers, Florida, United States
Teva Investigational Site 38
Hollywood, Florida, United States
Teva Investigational Site 23
Jacksonville, Florida, United States
Teva Investigational Site 65
Lake Worth, Florida, United States
Teva Investigational Site 156
Miami, Florida, United States
Teva Investigational Site 160
Orlando, Florida, United States
Teva Investigational Site 68
Orlando, Florida, United States
Teva Investigational Site 72
Augusta, Georgia, United States
Teva Investigational Site 50
Columbus, Georgia, United States
Teva Investigational Site 73
Macon, Georgia, United States
Teva Investigational Site 49
Centralia, Illinois, United States
Teva Investigational Site 48
Chicago, Illinois, United States
Teva Investigational Site 9
Chicago, Illinois, United States
Teva Investigational Site 14
Normal, Illinois, United States
Teva Investigational Site 24
Beech Grove, Indiana, United States
Teva Investigational Site 152
Indianapolis, Indiana, United States
Teva Investigational Site 31
Iowa City, Iowa, United States
Teva Investigational Site 63
Waterloo, Iowa, United States
Teva Investigational Site 47
Wichita, Kansas, United States
Teva Investigational Site 33
Lexington, Kentucky, United States
Teva Investigational Site 19
Shreveport, Louisiana, United States
Teva Investigational Site 43
Augusta, Maine, United States
Teva Investigational Site 74
Lowell, Massachusetts, United States
Teva Investigational Site 22
Duluth, Minnesota, United States
Teva Investigational Site 4
Saint Louis Park, Minnesota, United States
Teva Investigational Site 162
Columbia, Missouri, United States
Teva Investigational Site 157
Kansas City, Missouri, United States
Teva Investigational Site 29
Morristown, New Jersey, United States
Teva Investigational Site 46
Albuquerque, New Mexico, United States
Teva Investigational Site 8
Rochester, New York, United States
Teva Investigational Site 10
Syracuse, New York, United States
Teva Investigational Site 17
Charlotte, North Carolina, United States
Teva Investigational Site 151
Durham, North Carolina, United States
Teva Investigational Site 39
Fargo, North Dakota, United States
Teva Investigational Site 34
Cincinnati, Ohio, United States
Teva Investigational Site 60
Cincinnati, Ohio, United States
Teva Investigational Site 28
Cleveland, Ohio, United States
Teva Investigational Site 153
Springfield, Oregon, United States
Teva Investigational Site 59
Bethlehem, Pennsylvania, United States
Teva Investigational Site 44
Danville, Pennsylvania, United States
Teva Investigational Site 3
Philadelphia, Pennsylvania, United States
Teva Investigational Site 13
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 7
Pottstown, Pennsylvania, United States
Teva Investigational Site 25
Charleston, South Carolina, United States
Teva Investigational Site 71
Columbia, South Carolina, United States
Teva Investigational Site 56
Chattanooga, Tennessee, United States
Teva Investigational Site 30
Nashville, Tennessee, United States
Teva Investigational Site 154
Arlington, Texas, United States
Teva Investigational Site 158
Arlington, Texas, United States
Teva Investigational Site 6
El Paso, Texas, United States
Teva Investigational Site 161
Fort Worth, Texas, United States
Teva Investigational Site 159
San Antonio, Texas, United States
Teva Investigational Site 166
Sugar Land, Texas, United States
Teva Investigational Site 2
Salt Lake City, Utah, United States
Teva Investigational Site 18
Abingdon, Virginia, United States
Teva Investigational Site 35
Charlottesville, Virginia, United States
Teva Investigational Site 164
Norfolk, Virginia, United States
Teva Investigational Site 54
Richmond, Virginia, United States
Teva Investigational Site 42
Seattle, Washington, United States
Teva Investigational Site 150
Spokane, Washington, United States
Teva Investigational Site 163
Vancouver, Washington, United States
Teva Investigational Site 66
Morgantown, West Virginia, United States
Teva Investigational Site 41
Madison, Wisconsin, United States
Teva Investigational Site 62
Wausau, Wisconsin, United States
Teva Investigational Site 315
Perth, Western Australia, Australia
Teva Investigational Site 305
Concord, , Australia
Teva Investigational Site 317
Douglas, , Australia
Teva Investigational Site 308
East Melbourne, , Australia
Teva Investigational Site 310
Fitzroy, , Australia
Teva Investigational Site 311
Fitzroy, , Australia
Teva Investigational Site 301
Garran, , Australia
Teva Investigational Site 316
Geelong, , Australia
Teva Investigational Site 304
Hobart, , Australia
Teva Investigational Site 312
Kurralta Park, , Australia
Teva Investigational Site 307
Melbourne, , Australia
Teva Investigational Site 318
Parkville, , Australia
Teva Investigational Site 300
South Brisbane, , Australia
Teva Investigational Site 303
Westmead, , Australia
Teva Investigational Site 314
Wodonga, , Australia
Teva Investigational Site 313
Woodville, , Australia
Teva Investigational Site 309
Woolloongabba, , Australia
Teva Investigational Site 503
Barretos, , Brazil
Teva Investigational Site 504
Brasília, , Brazil
Teva Investigational Site 506
Curitiba, , Brazil
Teva Investigational Site 505
Goiânia, , Brazil
Teva Investigational Site 502
Jaú, , Brazil
Teva Investigational Site 509
Lajeado, , Brazil
Teva Investigational Site 507
Porto Alegre, , Brazil
Teva Investigational Site 508
Porto Alegre, , Brazil
Teva Investigational Site 511
Rio de Janeiro, , Brazil
Teva Investigational Site 500
Santo André, , Brazil
Teva Investigational Site 501
São Paulo, , Brazil
Teva Investigational Site 202
Barrie, , Canada
Teva Investigational Site 206
Calgary, , Canada
Teva Investigational Site 200
Halifax, , Canada
Teva Investigational Site 201
Ottawa, , Canada
Teva Investigational Site 203
Vancouver, , Canada
Teva Investigational Site 204
Winnipeg, , Canada
Teva Investigational Site 602
Aguascalientes, , Mexico
Teva Investigational Site 603
Hermosillo, , Mexico
Teva Investigational Site 600
Monterrey, , Mexico
Teva Investigational Site 601
Monterrey, , Mexico
Teva Investigational Site 401
Auckland, , New Zealand
Teva Investigational Site 405
Auckland, , New Zealand
Teva Investigational Site 400
Christchurch, , New Zealand
Teva Investigational Site 402
Newtown, , New Zealand
Teva Investigational Site 404
Palmerston North, , New Zealand
Teva Investigational Site 403
Takapuna, , New Zealand
Teva Investigational Site 700
Lima, , Peru
Teva Investigational Site 701
Lima, , Peru
Teva Investigational Site 704
Lima, , Peru
Teva Investigational Site 702
Miraflores, , Peru
Teva Investigational Site 703
Miraflores, , Peru
Countries
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References
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Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. doi: 10.1182/blood-2013-11-531327. Epub 2014 Mar 3.
Flinn IW, van der Jagt R, Kahl B, Wood P, Hawkins T, MacDonald D, Simpson D, Kolibaba K, Issa S, Chang J, Trotman J, Hallman D, Chen L, Burke JM. First-Line Treatment of Patients With Indolent Non-Hodgkin Lymphoma or Mantle-Cell Lymphoma With Bendamustine Plus Rituximab Versus R-CHOP or R-CVP: Results of the BRIGHT 5-Year Follow-Up Study. J Clin Oncol. 2019 Apr 20;37(12):984-991. doi: 10.1200/JCO.18.00605. Epub 2019 Feb 27.
Burke JM, van der Jagt RH, Kahl BS, Wood P, Hawkins TE, MacDonald D, Hertzberg M, Simpson D, Craig M, Kolibaba K, Issa S, Munteanu M, Victor TW, Flinn IW. Differences in Quality of Life Between Bendamustine-Rituximab and R-CHOP/R-CVP in Patients With Previously Untreated Advanced Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2016 Apr;16(4):182-190.e1. doi: 10.1016/j.clml.2016.01.001. Epub 2016 Jan 15.
Other Identifiers
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C18083/3064/NL/MN
Identifier Type: -
Identifier Source: org_study_id
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