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
Overview[ - collapse ][ - ]
Purpose | 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). |
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Condition | Non-Hodgkin's Lymphoma Mantle Cell Lymphoma |
Intervention | Drug: bendamustine Drug: rituximab Drug: vincristine Drug: prednisone Drug: cyclophosphamide Drug: doxorubicin |
Phase | Phase 3 |
Sponsor | Teva Branded Pharmaceutical Products, R&D Inc. |
Responsible Party | Teva Pharmaceutical Industries |
ClinicalTrials.gov Identifier | NCT00877006 |
First Received | April 3, 2009 |
Last Updated | March 25, 2014 |
Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | April 3, 2009 |
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Last Updated Date | March 25, 2014 |
Start Date | April 2009 |
Estimated Primary Completion Date | March 2017 |
Current Primary Outcome Measures | Percentage of Participants With Complete Response (CR) at End of Treatment Period [Time Frame: 6 to 8 21 or 28-day cycles (18-32 weeks)] [Designated as safety issue: No]CR=complete disappearance of all detectable clinical evidence of disease and disease-related symptoms, if present pretherapy; protocol-specified positron emission tomography (PET) scan assessment criteria; (if the spleen and/or liver were enlarged on the basis of physical examination and/or anatomic imaging before treatment) the liver and/or spleen were considered normal size on physical examination and by anatomic imaging after therapy, with disappearance of all nodules related to lymphoma; (if the bone marrow was involved by lymphoma before treatment) the infiltrate must have cleared on subsequent bone marrow biopsies. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | 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 |
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Official Title | An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) |
Brief 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). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: bendamustine Other Names:
Other Names:
Other Names: OncovinDrug: prednisone Drug: cyclophosphamide Other Names:
Other Names: Adriamycin |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Active, not recruiting |
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Estimated Enrollment | 447 |
Estimated Completion Date | March 2017 |
Estimated Primary Completion Date | March 2012 |
Eligibility Criteria | Key Inclusion Criteria: - Histopathologic confirmation of one of the following cluster of differentiation antigen 20 positive (CD20+) B-cell non-Hodgkin's lymphomas (tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available 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 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. Key Exclusion Criteria: - Chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), or grade 3 follicular lymphoma - 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. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Australia, Brazil, Canada, Mexico, New Zealand, Peru |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00877006 |
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Other Study ID Numbers | C18083/3064/NL/MN |
Has Data Monitoring Committee | Yes |
Information Provided By | Teva Pharmaceutical Industries |
Study Sponsor | Teva Branded Pharmaceutical Products, R&D Inc. |
Collaborators | Not Provided |
Investigators | Study Director: Sponsor's Medical Expert Cephalon |
Verification Date | March 2014 |
Locations[ + expand ][ + ]
Teva Investigational Site 165 | Tucson, Arizona, United States |
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Teva Investigational Site 167 | Little Rock, Arkansas, United States |
Teva Investigational Site 52 | Fountain Valley, California, United States |
Teva Investigational Site 21 | 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 65 | Lake Worth, Florida, United States |
Teva Investigational Site 68 | Orlando, Florida, United States |
Teva Investigational Site 160 | 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 9 | Chicago, Illinois, United States |
Teva Investigational Site 48 | Chicago, 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 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 | St. 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 46 | Albuquerque, New Mexico, United States |
Teva Investigational Site 10 | Syracuse, New York, United States |
Teva Investigational Site 17 | Charlotte, North Carolina, United States |
Teva Investigational Site 39 | Fargo, North Dakota, 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 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 158 | Arlington, Texas, United States |
Teva Investigational Site 154 | Arlington, 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 306 | North Terrace, 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-SP, Brazil |
Teva Investigational Site 504 | Brasilia, DF, Brazil |
Teva Investigational Site 502 | Jau, Brazil |
Teva Investigational Site 509 | Lajeado-RS, Brazil |
Teva Investigational Site 508 | Porto Alegre, Brazil |
Teva Investigational Site 507 | Porto Alegre, Brazil |
Teva Investigational Site 511 | Rio de Janeiro - RJ, Brazil |
Teva Investigational Site 500 | Santo Andre, Brazil |
Teva Investigational Site 501 | Sao 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, Sonora, Mexico |
Teva Investigational Site 601 | Monterrey, Mexico |
Teva Investigational Site 600 | Monterrey - NL, Mexico |
Teva Investigational Site 405 | Auckland, New Zealand |
Teva Investigational Site 401 | 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 701 | Lima, Peru |
Teva Investigational Site 704 | Lima, Peru |
Teva Investigational Site 700 | Lima, Peru |
Teva Investigational Site 702 | Miraflores, Peru |
Teva Investigational Site 703 | Miraflores, Peru |