AzTrials
AzTrials

Non-Hodgkin's LymphomaPhase 3NCT00877006

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

A Phase 3 study testing bendamustine, rituximab and vincristine in people with Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 128 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
What is being tested?
bendamustine, rituximab and vincristine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
447 participants
Where
128 sitesin 7 countries
Study dates
30 Apr 2009to 31 Mar 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 30Show fewer
  • 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:
  • fever (>38ºC) of unclear etiology
  • night sweats
  • 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.

Who cannot join

  • 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)
Show all 15Show fewer
  • 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.

Trial locations and contacts

128 sites in 7 countries.

128 sites in 7 countries

United States79 sites

  • Teva Investigational Site 18

    Abingdon, Virginia

  • Teva Investigational Site 46

    Albuquerque, New Mexico

  • Teva Investigational Site 154

    Arlington, Texas

  • Teva Investigational Site 158

    Arlington, Texas

  • Teva Investigational Site 72

    Augusta, Georgia

  • Teva Investigational Site 43

    Augusta, Maine

  • Teva Investigational Site 15

    Aurora, Colorado

  • Teva Investigational Site 24

    Beech Grove, Indiana

  • Teva Investigational Site 59

    Bethlehem, Pennsylvania

  • Teva Investigational Site 49

    Centralia, Illinois

  • Teva Investigational Site 25

    Charleston, South Carolina

  • Teva Investigational Site 17

    Charlotte, North Carolina

  • Teva Investigational Site 35

    Charlottesville, Virginia

  • Teva Investigational Site 56

    Chattanooga, Tennessee

  • Teva Investigational Site 48

    Chicago, Illinois

  • Teva Investigational Site 9

    Chicago, Illinois

  • Teva Investigational Site 34

    Cincinnati, Ohio

  • Teva Investigational Site 60

    Cincinnati, Ohio

  • Teva Investigational Site 28

    Cleveland, Ohio

  • Teva Investigational Site 162

    Columbia, Missouri

  • Teva Investigational Site 71

    Columbia, South Carolina

  • Teva Investigational Site 50

    Columbus, Georgia

  • Teva Investigational Site 11

    Corona, California

  • Teva Investigational Site 44

    Danville, Pennsylvania

  • Teva Investigational Site 155

    Denver, Colorado

  • Teva Investigational Site 22

    Duluth, Minnesota

  • Teva Investigational Site 151

    Durham, North Carolina

  • Teva Investigational Site 6

    El Paso, Texas

  • Teva Investigational Site 39

    Fargo, North Dakota

  • Teva Investigational Site 5

    Fort Collins, Colorado

  • Teva Investigational Site 58

    Fort Myers, Florida

  • Teva Investigational Site 161

    Fort Worth, Texas

  • Teva Investigational Site 21

    Fountain Valley, California

  • Teva Investigational Site 52

    Fountain Valley, California

  • Teva Investigational Site 64

    Fullerton, California

  • Teva Investigational Site 38

    Hollywood, Florida

  • Teva Investigational Site 152

    Indianapolis, Indiana

  • Teva Investigational Site 31

    Iowa City, Iowa

  • Teva Investigational Site 23

    Jacksonville, Florida

  • Teva Investigational Site 157

    Kansas City, Missouri

  • Teva Investigational Site 65

    Lake Worth, Florida

  • Teva Investigational Site 33

    Lexington, Kentucky

  • Teva Investigational Site 167

    Little Rock, Arkansas

  • Teva Investigational Site 40

    Los Angeles, California

  • Teva Investigational Site 53

    Los Angeles, California

  • Teva Investigational Site 74

    Lowell, Massachusetts

  • Teva Investigational Site 73

    Macon, Georgia

  • Teva Investigational Site 41

    Madison, Wisconsin

  • Teva Investigational Site 156

    Miami, Florida

  • Teva Investigational Site 66

    Morgantown, West Virginia

  • Teva Investigational Site 29

    Morristown, New Jersey

  • Teva Investigational Site 30

    Nashville, Tennessee

  • Teva Investigational Site 70

    New Britain, Connecticut

  • Teva Investigational Site 164

    Norfolk, Virginia

  • Teva Investigational Site 14

    Normal, Illinois

  • Teva Investigational Site 37

    Norwalk, Connecticut

  • Teva Investigational Site 160

    Orlando, Florida

  • Teva Investigational Site 68

    Orlando, Florida

  • Teva Investigational Site 3

    Philadelphia, Pennsylvania

  • Teva Investigational Site 13

    Pittsburgh, Pennsylvania

  • Teva Investigational Site 7

    Pottstown, Pennsylvania

  • Teva Investigational Site 54

    Richmond, Virginia

  • Teva Investigational Site 8

    Rochester, New York

  • Teva Investigational Site 4

    Saint Louis Park, Minnesota

  • Teva Investigational Site 2

    Salt Lake City, Utah

  • Teva Investigational Site 159

    San Antonio, Texas

  • Teva Investigational Site 57

    San Diego, California

  • Teva Investigational Site 42

    Seattle, Washington

  • Teva Investigational Site 19

    Shreveport, Louisiana

  • Teva Investigational Site 67

    Southington, Connecticut

  • Teva Investigational Site 150

    Spokane, Washington

  • Teva Investigational Site 153

    Springfield, Oregon

  • Teva Investigational Site 166

    Sugar Land, Texas

  • Teva Investigational Site 10

    Syracuse, New York

  • Teva Investigational Site 165

    Tucson, Arizona

  • Teva Investigational Site 163

    Vancouver, Washington

  • Teva Investigational Site 63

    Waterloo, Iowa

  • Teva Investigational Site 62

    Wausau, Wisconsin

  • Teva Investigational Site 47

    Wichita, Kansas

Other trials in United States

Australia17 sites

  • Teva Investigational Site 305

    Concord

  • Teva Investigational Site 317

    Douglas

  • Teva Investigational Site 308

    East Melbourne

  • Teva Investigational Site 310

    Fitzroy

  • Teva Investigational Site 311

    Fitzroy

  • Teva Investigational Site 301

    Garran

  • Teva Investigational Site 316

    Geelong

  • Teva Investigational Site 304

    Hobart

  • Teva Investigational Site 312

    Kurralta Park

  • Teva Investigational Site 307

    Melbourne

  • Teva Investigational Site 318

    Parkville

  • Teva Investigational Site 315

    Perth, Western Australia

  • Teva Investigational Site 300

    South Brisbane

  • Teva Investigational Site 303

    Westmead

  • Teva Investigational Site 314

    Wodonga

  • Teva Investigational Site 313

    Woodville

  • Teva Investigational Site 309

    Woolloongabba

Other trials in Australia

Brazil11 sites

  • Teva Investigational Site 503

    Barretos

  • Teva Investigational Site 504

    Brasília

  • Teva Investigational Site 506

    Curitiba

  • Teva Investigational Site 505

    Goiânia

  • Teva Investigational Site 502

    Jaú

  • Teva Investigational Site 509

    Lajeado

  • Teva Investigational Site 507

    Porto Alegre

  • Teva Investigational Site 508

    Porto Alegre

  • Teva Investigational Site 511

    Rio de Janeiro

  • Teva Investigational Site 500

    Santo André

  • Teva Investigational Site 501

    São Paulo

Other trials in Brazil

Canada6 sites

  • Teva Investigational Site 202

    Barrie

  • Teva Investigational Site 206

    Calgary

  • Teva Investigational Site 200

    Halifax

  • Teva Investigational Site 201

    Ottawa

  • Teva Investigational Site 203

    Vancouver

  • Teva Investigational Site 204

    Winnipeg

Other trials in Canada

New Zealand6 sites

  • Teva Investigational Site 401

    Auckland

  • Teva Investigational Site 405

    Auckland

  • Teva Investigational Site 400

    Christchurch

  • Teva Investigational Site 402

    Newtown

  • Teva Investigational Site 404

    Palmerston North

  • Teva Investigational Site 403

    Takapuna

Other trials in New Zealand

Peru5 sites

  • Teva Investigational Site 700

    Lima

  • Teva Investigational Site 701

    Lima

  • Teva Investigational Site 704

    Lima

  • Teva Investigational Site 702

    Miraflores

  • Teva Investigational Site 703

    Miraflores

Other trials in Peru

Mexico4 sites

  • Teva Investigational Site 602

    Aguascalientes

  • Teva Investigational Site 603

    Hermosillo

  • Teva Investigational Site 600

    Monterrey

  • Teva Investigational Site 601

    Monterrey

Other trials in Mexico

About this study

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)

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).

Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00877006
Study groupRoleWhat they receive
Bendamustine and Rituximab (BR)ExperimentalParticipants 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
Receives: Drug: bendamustine; Drug: rituximab
R-CHOP/R-CVPActive comparatorParticipants 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
Receives: Drug: rituximab; Drug: vincristine; Drug: prednisone; Drug: cyclophosphamide; Drug: doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Complete Response (CR) at End of Treatment Period

    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.

    Measured: 6 to 8 21 or 28-day cycles (18-32 weeks)

Secondary outcomes (16)

  1. Percentage of Participants With Overall Response at End of Treatment Period

    Overall Response=participants with Complete Remission (CR) + those with Partial Remission (PR). CR=see Outcome Measure 1 for details. PR= at least a 50% decrease in the sum of the product of the greatest diameters (SPD) of up to 6 of the largest dominant nodes/masses; at least a 50% decrease in the SPD of hepatic and splenic nodules in their greatest transverse diameter; no increase in the size of the liver, spleen, and other nodes; no measurable disease in organs other than the liver or spleen; no new sites of disease; protocol-specified PET scan and bone marrow criteria.

    Measured: 6 to 8 21 or 28-day cycles (18-32 weeks)

  2. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period

    AE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. An AE can, therefore, be any unfavorable and unintended physical sign, symptom, or laboratory parameter that develops or worsens in severity during the course of the study, or significant worsening of the disease under study (or any concurrent disease), whether or not considered related to the study drug. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). SAE=an adverse event occurring at any dose that results in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity (a substantial disruption of one's ability to conduct normal life functions), a congenital anomaly/birth defect, or other important medical event.

    Measured: 32 weeks

  3. Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results

    Clinical laboratory data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for serum chemistry test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and laboratory test across all cycles).

    Measured: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)

  4. Worst Overall CTCAE Grade for Hematology Laboratory Test Results

    Hematology test data were graded according to National Cancer Institute's (NCI) CTCAE version 3, and graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). The table presents the worst CTCAE grades for hematology test results experienced by participants overall (i.e., the worst post-baseline grade value for each participant and hematology test across all cycles).

    Measured: 32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)

  5. Clinically Significant Abnormal Vital Signs

    Measured: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)

  6. Potentially Clinically Significant Abnormal Weight

    Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant.

    Measured: Baseline, Week 32

  7. Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period

    Participants' ECOG Performance Status was evaluated at the end of treatment as improved, stayed the same, or worsened from baseline (see Baseline Characteristics for ECOG Performance Status).

    Measured: Week 32

  8. Therapeutic Classification of Prior Medications

    Measured: prior to start of treatment

  9. Therapeutic Classification of Concomitant Medications

    Measured: 32 weeks

  10. Change From Baseline to End of Treatment in the Global Health Status Score of the European Organization for Research and Treatment of Cancer (EORTC) 30-item Core Quality of Life Questionnaire (QLQ-C30)

    EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). This outcome reports the global health status on a scale of 0-100 with a high score for the global health status/QOL represents a high quality of life.

    Measured: Day 1 (prior to treatment), 32 weeks

  11. Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period

    Relapsed disease (after CR) and progressive disease (PD) (after PR or SD):

    • Lymph nodes were considered abnormal if the long axis was greater than 1.5 cm. Lymph nodes with a long axis of 1.1 to 1.5 cm were considered abnormal if its short axis was greater than 1.0 cm.
    • In patients with no prior history of pulmonary lymphoma, new lung nodules identified by CT require histologic confirmation.
    • >= 50% increase from nadir in sum of the products of the greatest diameters (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must have increased by 2: 50% and to a size of 1.5 cm by 1.5 cm, or more than 1.5 cm in the long axis
    • other conditions as specified in the protocol

    Measured: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period

  12. Kaplan-Meier Estimate for Progression-free Survival (PFS)

    PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first.

    Measured: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

  13. Kaplan-Meier Estimate for Event-free Survival (EFS)

    EFS was defined as the time from randomization to treatment failure, disease progression or relapse, other malignancies, or death from any cause, whichever occurred first.

    Treatment failure was defined as failure to achieve a CR or PR after 6 cycles of treatment. If a patient failed to achieve CR or PR by the time of data analysis or early withdrawal, the treatment failure date was set at 126 days (6 cycles of treatment) after randomization or the new anticancer treatment date, whichever is earlier.

    Measured: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

  14. Kaplan-Meier Estimate for Duration of Response (DOR)

    DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause.

    Measured: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

  15. Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause.

    Measured: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

  16. Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period

    Death is due to any cause. Data are broken out by patients who died within 30 days of the last dose of study medications, and those who died greater than 30 days of the last dose of study medications.

    Measured: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2009 (estimated)
  2. Study start30 Apr 2009
  3. Primary completion31 Mar 2012
  4. Study completion31 Mar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00877006
Sponsor's protocol ID
C18083/3064/NL/MN
Status last verified
Jan 2018
First submitted
3 Apr 2009
Last updated
5 Feb 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24591201

  • 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.

    PubMed 30811293

  • 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.

    PubMed 26875824

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bendamustine, rituximab and vincristine in people with Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 128 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, Australia, Brazil, Canada, New Zealand and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00877006, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.

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