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

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.

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

Population: 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.

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.

Time frame: Day 1 (prior to treatment), 32 weeks

Population: The set of randomized participants (intent-to-treat) consisting of all patients randomly assigned to treatment, and who had data at both timepoints.

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

Population: 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' 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).

Time frame: Week 32

Population: 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.

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

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

Population: Randomized patients with complete response (CR) or partial response (PR)

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.

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

Population: Randomized patients

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

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

Population: Randomized patients

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.

Time frame: 32 weeks

Population: 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.

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

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

Population: Randomized patients

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.

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

Population: Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment.

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

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

Population: Randomized patients: the set of randomized patients (intent-to-treat) consists of all patients randomly assigned to treatment.

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.

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

Population: 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.

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

Time frame: Baseline, Week 32

Population: 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.

Time frame: 32 weeks

Population: 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.

Time frame: prior to start of treatment

Population: Safety Analysis Set: all participants randomly assigned to a treatment group

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).

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

Population: 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.

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).

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

Population: 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.