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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00877006
Registration number
NCT00877006
Ethics application status
Date submitted
3/04/2009
Date registered
7/04/2009
Date last updated
5/02/2018
Titles & IDs
Public 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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Scientific 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)
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Secondary ID [1]
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C18083/3064/NL/MN
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma
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Mantle Cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - bendamustine
Treatment: Drugs - rituximab
Treatment: Drugs - vincristine
Treatment: Drugs - prednisone
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - doxorubicin
Experimental: 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
Active Comparator: 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
Treatment: Drugs: bendamustine
Treatment: Drugs: rituximab
Treatment: Drugs: vincristine
Treatment: Drugs: prednisone
Treatment: Drugs: cyclophosphamide
Treatment: Drugs: doxorubicin
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Complete Response (CR) at End of Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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6 to 8 21 or 28-day cycles (18-32 weeks)
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Secondary outcome [1]
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Percentage of Participants With Overall Response at End of Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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6 to 8 21 or 28-day cycles (18-32 weeks)
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Secondary outcome [2]
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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period
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Assessment method [2]
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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.
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Timepoint [2]
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32 weeks
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Secondary outcome [3]
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Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results
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Assessment method [3]
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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).
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Timepoint [3]
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32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
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Secondary outcome [4]
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Worst Overall CTCAE Grade for Hematology Laboratory Test Results
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Assessment method [4]
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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).
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Timepoint [4]
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32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)
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Secondary outcome [5]
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Clinically Significant Abnormal Vital Signs
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Assessment method [5]
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Timepoint [5]
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32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
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Secondary outcome [6]
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Potentially Clinically Significant Abnormal Weight
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Assessment method [6]
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Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of >=10% were considered potentially clinically significant.
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Timepoint [6]
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Baseline, Week 32
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Secondary outcome [7]
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Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period
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Assessment method [7]
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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).
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Timepoint [7]
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Week 32
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Secondary outcome [8]
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Therapeutic Classification of Prior Medications
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Assessment method [8]
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Timepoint [8]
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prior to start of treatment
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Secondary outcome [9]
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Therapeutic Classification of Concomitant Medications
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Assessment method [9]
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Timepoint [9]
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32 weeks
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Secondary outcome [10]
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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)
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Assessment method [10]
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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.
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Timepoint [10]
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Day 1 (prior to treatment), 32 weeks
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Secondary outcome [11]
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Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period
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Assessment method [11]
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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
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Timepoint [11]
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Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period
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Secondary outcome [12]
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Kaplan-Meier Estimate for Progression-free Survival (PFS)
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Assessment method [12]
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PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first.
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Timepoint [12]
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Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
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Secondary outcome [13]
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Kaplan-Meier Estimate for Event-free Survival (EFS)
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Assessment method [13]
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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.
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Timepoint [13]
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Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
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Secondary outcome [14]
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Kaplan-Meier Estimate for Duration of Response (DOR)
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Assessment method [14]
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DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause.
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Timepoint [14]
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Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
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Secondary outcome [15]
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Overall Survival (OS)
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Assessment method [15]
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OS was defined as the time from randomization to death from any cause.
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Timepoint [15]
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Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
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Secondary outcome [16]
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Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period
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Assessment method [16]
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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.
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Timepoint [16]
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Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period
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Eligibility
Key inclusion criteria
Key
- 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/04/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2012
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Sample size
Target
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Accrual to date
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Final
447
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Teva Investigational Site 315 - Perth
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Recruitment hospital [2]
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Teva Investigational Site 305 - Concord
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Teva Investigational Site 317 - Douglas
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Teva Investigational Site 308 - East Melbourne
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Teva Investigational Site 310 - Fitzroy
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Teva Investigational Site 311 - Fitzroy
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Teva Investigational Site 301 - Garran
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Teva Investigational Site 316 - Geelong
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Recruitment hospital [9]
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Teva Investigational Site 304 - Hobart
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Recruitment hospital [10]
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Teva Investigational Site 312 - Kurralta Park
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Recruitment hospital [11]
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Teva Investigational Site 307 - Melbourne
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Recruitment hospital [12]
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Teva Investigational Site 318 - Parkville
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Recruitment hospital [13]
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Teva Investigational Site 300 - South Brisbane
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Teva Investigational Site 303 - Westmead
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Recruitment hospital [15]
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Teva Investigational Site 314 - Wodonga
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Recruitment hospital [16]
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Teva Investigational Site 313 - Woodville
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Recruitment hospital [17]
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Teva Investigational Site 309 - Woolloongabba
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Recruitment postcode(s) [1]
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- Perth
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Recruitment postcode(s) [2]
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- Concord
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- Douglas
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- East Melbourne
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- Fitzroy
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- Garran
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- Geelong
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Recruitment postcode(s) [8]
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- Hobart
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Recruitment postcode(s) [9]
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- Kurralta Park
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Recruitment postcode(s) [10]
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- Melbourne
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Recruitment postcode(s) [11]
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- Parkville
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Recruitment postcode(s) [12]
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- South Brisbane
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Recruitment postcode(s) [13]
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- Westmead
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Recruitment postcode(s) [14]
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- Wodonga
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Recruitment postcode(s) [15]
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- Woodville
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Recruitment postcode(s) [16]
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- Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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Arizona
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Arkansas
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Louisiana
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Maine
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Massachusetts
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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0
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Wisconsin
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0
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Brazil
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Barretos
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0
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Brazil
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Brasilia
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0
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Brazil
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Curitiba
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Brazil
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Goiânia
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0
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Brazil
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Jau
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0
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Brazil
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Lajeado
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0
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Brazil
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0
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Porto Alegre
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Country [41]
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Brazil
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State/province [41]
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Rio De Janeiro
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Country [42]
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Brazil
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Santo Andre
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Country [43]
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Brazil
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Sao Paulo
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Canada
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Barrie
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Country [45]
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Canada
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Calgary
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Country [46]
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Canada
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Halifax
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Canada
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Ottawa
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Country [48]
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Canada
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Vancouver
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Canada
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Winnipeg
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Country [50]
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Mexico
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Aguascalientes
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Country [51]
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Mexico
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Hermosillo
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Mexico
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Monterrey
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Country [55]
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New Zealand
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Newtown
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Country [56]
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New Zealand
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State/province [56]
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Palmerston North
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Country [57]
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New Zealand
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Takapuna
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Country [58]
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Peru
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State/province [58]
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Lima
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Country [59]
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Peru
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State/province [59]
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Miraflores
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Teva Branded Pharmaceutical Products R&D, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00877006
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Sponsor's Medical Expert
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Address
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Cephalon
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00877006
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