Trial · NCT00877006

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

NCT00877006, Phase 3, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2014-04-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT00877006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00877006

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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
NCT number: NCT00877006
Status: Completed
Phases: Phase 3
Enrollment: 447 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
Interventions: bendamustine, rituximab, vincristine, prednisone, cyclophosphamide, doxorubicin
First posted: 2009-04-07
Last updated: 2018-02-05
Results first posted: 2014-04-28

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With Complete Response (CR) at End of Treatment Period	6 to 8 21 or 28-day cycles (18-32 weeks)	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.
Secondary	Percentage of Participants With Overall Response at End of Treatment Period	6 to 8 21 or 28-day cycles (18-32 weeks)	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.
Secondary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period	32 weeks	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.
Secondary	Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results	32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)	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).
Secondary	Worst Overall CTCAE Grade for Hematology Laboratory Test Results	32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)	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).
Secondary	Clinically Significant Abnormal Vital Signs	32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
Secondary	Potentially Clinically Significant Abnormal Weight	Baseline, Week 32	Participants were weighed at Baseline and at Endpoint (Week 32); those participants with an increase or decrease of \>=10% were considered potentially clinically significant.
Secondary	Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period	Week 32	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).
Secondary	Therapeutic Classification of Prior Medications	prior to start of treatment
Secondary	Therapeutic Classification of Concomitant Medications	32 weeks

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With Complete Response (CR) at End of Treatment Period	6 to 8 21 or 28-day cycles (18-32 weeks)	Evaluable Analysis Set: treated participants with a baseline and \>=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging \[CT/MRI\] or positron emission tomography \[PET\] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Overall Response at End of Treatment Period	6 to 8 21 or 28-day cycles (18-32 weeks)	Evaluable Analysis Set: treated participants with a baseline and \>=1 post-baseline response evaluation (based on computed tomography/magnetic resonance imaging \[CT/MRI\] or positron emission tomography \[PET\] and clinical data), or who discontinued treatment due to progressive disease and had no major protocol violations.	percentage of participants	NUMBER
SECONDARY	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period	32 weeks	Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.	participants	NUMBER
SECONDARY	Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results	32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)	Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had a post-baseline assessment.	participants	NUMBER
SECONDARY	Worst Overall CTCAE Grade for Hematology Laboratory Test Results	32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)	Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and who had an assessment.	participants	NUMBER
SECONDARY	Clinically Significant Abnormal Vital Signs	32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)	Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and had baseline and post-baseline values.	participants	NUMBER
SECONDARY	Potentially Clinically Significant Abnormal Weight	Baseline, Week 32	Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen with a baseline and post-baseline weight.	participants	NUMBER
SECONDARY	Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period	Week 32	Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen and with baseline and post-baseline values.	participants	NUMBER
SECONDARY	Therapeutic Classification of Prior Medications	prior to start of treatment	Safety Analysis Set: all participants randomly assigned to a treatment group	participants	NUMBER
SECONDARY	Therapeutic Classification of Concomitant Medications	32 weeks	Safety Analysis Set: all participants randomly assigned to a treatment group who received 1 or more doses of any component of any study drug regimen.	participants	NUMBER

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group330

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants With Complete Response (CR) at End of Treatment Period	Bendamustine and Rituximab (BR)		31	95% Confidence Interval 25.3 to 38.2	percentage of participants
Percentage of Participants With Complete Response (CR) at End of Treatment Period	R-CHOP/R-CVP		25	95% Confidence Interval 19.5 to 31.7	percentage of participants
Percentage of Participants With Overall Response at End of Treatment Period	Bendamustine and Rituximab (BR)		97	95% Confidence Interval 93.3 to 98.7	percentage of participants
Percentage of Participants With Overall Response at End of Treatment Period	R-CHOP/R-CVP		91	95% Confidence Interval 86.0 to 94.4	percentage of participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period	Bendamustine and Rituximab (BR)	Any AE	221		participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period	R-CHOP/R-CVP	Any AE	213		participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period	Bendamustine and Rituximab (BR)	Severe AEs (grades 3, 4, 5)	130		participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period	R-CHOP/R-CVP	Severe AEs (grades 3, 4, 5)	127		participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period	Bendamustine and Rituximab (BR)	Treatment-related AEs	209		participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period	R-CHOP/R-CVP	Treatment-related AEs	NA		participants

1 to 10 of 330Source ClinicalTrials.gov

See all 330 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Bendamustine and Rituximab (BR)	224
Treatment Period	STARTED	R-CHOP/R-CVP	223
Treatment Period	COMPLETED	Bendamustine and Rituximab (BR)	199
Treatment Period	COMPLETED	R-CHOP/R-CVP	196
Treatment Period	NOT COMPLETED	Bendamustine and Rituximab (BR)	25
Treatment Period	NOT COMPLETED	R-CHOP/R-CVP	27
Long-Term Follow-up Period	STARTED	Bendamustine and Rituximab (BR)	210
Long-Term Follow-up Period	STARTED	R-CHOP/R-CVP	209
Long-Term Follow-up Period	COMPLETED	Bendamustine and Rituximab (BR)	157
Long-Term Follow-up Period	COMPLETED	R-CHOP/R-CVP	154

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events304

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Bendamustine and Rituximab (BR)	31	221	63
other	Anaemia	Blood and lymphatic system disorders	R-CHOP/CVP	29	215	69
other	Febrile neutropenia	Blood and lymphatic system disorders	Bendamustine and Rituximab (BR)	7	221	9
other	Febrile neutropenia	Blood and lymphatic system disorders	R-CHOP/CVP	11	215	12
other	Leukopenia	Blood and lymphatic system disorders	Bendamustine and Rituximab (BR)	21	221	79
other	Leukopenia	Blood and lymphatic system disorders	R-CHOP/CVP	22	215	88
other	Lymphopenia	Blood and lymphatic system disorders	Bendamustine and Rituximab (BR)	14	221	104
other	Lymphopenia	Blood and lymphatic system disorders	R-CHOP/CVP	12	215	44
other	Neutropenia	Blood and lymphatic system disorders	Bendamustine and Rituximab (BR)	76	221	251
other	Neutropenia	Blood and lymphatic system disorders	R-CHOP/CVP	85	215	255

1 to 10 of 304Source ClinicalTrials.gov

See all 304 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Bendamustine and Rituximab (BR)
Total, all-cause mortality	R-CHOP/CVP
Total, other adverse events	Bendamustine and Rituximab (BR)	216	221
Total, other adverse events	R-CHOP/CVP	211	215
Total, serious adverse events	Bendamustine and Rituximab (BR)	60	221
Total, serious adverse events	R-CHOP/CVP	49	215

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24591201	RESULT	PubMed
26875824	DERIVED	PubMed
30811293	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Bendamustine and Rituximab (BR) vs R-CHOP/R-CVP: Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period	Trial comparisons
Bendamustine and Rituximab (BR) vs R-CHOP/CVP: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00877006

GET https://conductscience.org/api/trials/v1/NCT00877006/results?page=2

API reference For AI assistants