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

January 8, 2018 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
447

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Concord, Australia
        • Teva Investigational Site 305
      • Douglas, Australia
        • Teva Investigational Site 317
      • East Melbourne, Australia
        • Teva Investigational Site 308
      • Fitzroy, Australia
        • Teva Investigational Site 310
      • Fitzroy, Australia
        • Teva Investigational Site 311
      • Garran, Australia
        • Teva Investigational Site 301
      • Geelong, Australia
        • Teva Investigational Site 316
      • Hobart, Australia
        • Teva Investigational Site 304
      • Kurralta Park, Australia
        • Teva Investigational Site 312
      • Melbourne, Australia
        • Teva Investigational Site 307
      • Parkville, Australia
        • Teva Investigational Site 318
      • South Brisbane, Australia
        • Teva Investigational Site 300
      • Westmead, Australia
        • Teva Investigational Site 303
      • Wodonga, Australia
        • Teva Investigational Site 314
      • Woodville, Australia
        • Teva Investigational Site 313
      • Woolloongabba, Australia
        • Teva Investigational Site 309
    • Western Australia
      • Perth, Western Australia, Australia
        • Teva Investigational Site 315
  • Brazil
      • Barretos, Brazil
        • Teva Investigational Site 503
      • Brasilia, Brazil
        • Teva Investigational Site 504
      • Curitiba, Brazil
        • Teva Investigational Site 506
      • Goiânia, Brazil
        • Teva Investigational Site 505
      • Jau, Brazil
        • Teva Investigational Site 502
      • Lajeado, Brazil
        • Teva Investigational Site 509
      • Porto Alegre, Brazil
        • Teva Investigational Site 507
      • Porto Alegre, Brazil
        • Teva Investigational Site 508
      • Rio De Janeiro, Brazil
        • Teva Investigational Site 511
      • Santo Andre, Brazil
        • Teva Investigational Site 500
      • Sao Paulo, Brazil
        • Teva Investigational Site 501
  • Canada
      • Barrie, Canada
        • Teva Investigational Site 202
      • Calgary, Canada
        • Teva Investigational Site 206
      • Halifax, Canada
        • Teva Investigational Site 200
      • Ottawa, Canada
        • Teva Investigational Site 201
      • Vancouver, Canada
        • Teva Investigational Site 203
      • Winnipeg, Canada
        • Teva Investigational Site 204
  • Mexico
      • Aguascalientes, Mexico
        • Teva Investigational Site 602
      • Hermosillo, Mexico
        • Teva Investigational Site 603
      • Monterrey, Mexico
        • Teva Investigational Site 600
      • Monterrey, Mexico
        • Teva Investigational Site 601
  • New Zealand
      • Auckland, New Zealand
        • Teva Investigational Site 401
      • Auckland, New Zealand
        • Teva Investigational Site 405
      • Christchurch, New Zealand
        • Teva Investigational Site 400
      • Newtown, New Zealand
        • Teva Investigational Site 402
      • Palmerston North, New Zealand
        • Teva Investigational Site 404
      • Takapuna, New Zealand
        • Teva Investigational Site 403
  • Peru
      • Lima, Peru
        • Teva Investigational Site 700
      • Lima, Peru
        • Teva Investigational Site 701
      • Lima, Peru
        • Teva Investigational Site 704
      • Miraflores, Peru
        • Teva Investigational Site 702
      • Miraflores, Peru
        • Teva Investigational Site 703
  • United States
    • Arizona
      • Tucson, Arizona, United States
        • Teva Investigational Site 165
    • Arkansas
      • Little Rock, Arkansas, United States
        • Teva Investigational Site 167
    • California
      • Corona, California, United States
        • Teva Investigational Site 11
      • Fountain Valley, California, United States
        • Teva Investigational Site 21
      • Fountain Valley, California, United States
        • Teva Investigational Site 52
      • Fullerton, California, United States
        • Teva Investigational Site 64
      • Los Angeles, California, United States
        • Teva Investigational Site 40
      • Los Angeles, California, United States
        • Teva Investigational Site 53
      • San Diego, California, United States
        • Teva Investigational Site 57
    • Colorado
      • Aurora, Colorado, United States
        • Teva Investigational Site 15
      • Denver, Colorado, United States
        • Teva Investigational Site 155
      • Fort Collins, Colorado, United States
        • Teva Investigational Site 5
    • Connecticut
      • New Britain, Connecticut, United States
        • Teva Investigational Site 70
      • Norwalk, Connecticut, United States
        • Teva Investigational Site 37
      • Southington, Connecticut, United States
        • Teva Investigational Site 67
    • Florida
      • Fort Myers, Florida, United States
        • Teva Investigational Site 58
      • Hollywood, Florida, United States
        • Teva Investigational Site 38
      • Jacksonville, Florida, United States
        • Teva Investigational Site 23
      • Lake Worth, Florida, United States
        • Teva Investigational Site 65
      • Miami, Florida, United States
        • Teva Investigational Site 156
      • Orlando, Florida, United States
        • Teva Investigational Site 160
      • Orlando, Florida, United States
        • Teva Investigational Site 68
    • Georgia
      • Augusta, Georgia, United States
        • Teva Investigational Site 72
      • Columbus, Georgia, United States
        • Teva Investigational Site 50
      • Macon, Georgia, United States
        • Teva Investigational Site 73
    • Illinois
      • Centralia, Illinois, United States
        • Teva Investigational Site 49
      • Chicago, Illinois, United States
        • Teva Investigational Site 48
      • Chicago, Illinois, United States
        • Teva Investigational Site 9
      • Normal, Illinois, United States
        • Teva Investigational Site 14
    • Indiana
      • Beech Grove, Indiana, United States
        • Teva Investigational Site 24
      • Indianapolis, Indiana, United States
        • Teva Investigational Site 152
    • Iowa
      • Iowa City, Iowa, United States
        • Teva Investigational Site 31
      • Waterloo, Iowa, United States
        • Teva Investigational Site 63
    • Kansas
      • Wichita, Kansas, United States
        • Teva Investigational Site 47
    • Kentucky
      • Lexington, Kentucky, United States
        • Teva Investigational Site 33
    • Louisiana
      • Shreveport, Louisiana, United States
        • Teva Investigational Site 19
    • Maine
      • Augusta, Maine, United States
        • Teva Investigational Site 43
    • Massachusetts
      • Lowell, Massachusetts, United States
        • Teva Investigational Site 74
    • Minnesota
      • Duluth, Minnesota, United States
        • Teva Investigational Site 22
      • Saint Louis Park, Minnesota, United States
        • Teva Investigational Site 4
    • Missouri
      • Columbia, Missouri, United States
        • Teva Investigational Site 162
      • Kansas City, Missouri, United States
        • Teva Investigational Site 157
    • New Jersey
      • Morristown, New Jersey, United States
        • Teva Investigational Site 29
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Teva Investigational Site 46
    • New York
      • Rochester, New York, United States
        • Teva Investigational Site 8
      • Syracuse, New York, United States
        • Teva Investigational Site 10
    • North Carolina
      • Charlotte, North Carolina, United States
        • Teva Investigational Site 17
      • Durham, North Carolina, United States
        • Teva Investigational Site 151
    • North Dakota
      • Fargo, North Dakota, United States
        • Teva Investigational Site 39
    • Ohio
      • Cincinnati, Ohio, United States
        • Teva Investigational Site 34
      • Cincinnati, Ohio, United States
        • Teva Investigational Site 60
      • Cleveland, Ohio, United States
        • Teva Investigational Site 28
    • Oregon
      • Springfield, Oregon, United States
        • Teva Investigational Site 153
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
        • Teva Investigational Site 59
      • Danville, Pennsylvania, United States
        • Teva Investigational Site 44
      • Philadelphia, Pennsylvania, United States
        • Teva Investigational Site 3
      • Pittsburgh, Pennsylvania, United States
        • Teva Investigational Site 13
      • Pottstown, Pennsylvania, United States
        • Teva Investigational Site 7
    • South Carolina
      • Charleston, South Carolina, United States
        • Teva Investigational Site 25
      • Columbia, South Carolina, United States
        • Teva Investigational Site 71
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Teva Investigational Site 56
      • Nashville, Tennessee, United States
        • Teva Investigational Site 30
    • Texas
      • Arlington, Texas, United States
        • Teva Investigational Site 154
      • Arlington, Texas, United States
        • Teva Investigational Site 158
      • El Paso, Texas, United States
        • Teva Investigational Site 6
      • Fort Worth, Texas, United States
        • Teva Investigational Site 161
      • San Antonio, Texas, United States
        • Teva Investigational Site 159
      • Sugar Land, Texas, United States
        • Teva Investigational Site 166
    • Utah
      • Salt Lake City, Utah, United States
        • Teva Investigational Site 2
    • Virginia
      • Abingdon, Virginia, United States
        • Teva Investigational Site 18
      • Charlottesville, Virginia, United States
        • Teva Investigational Site 35
      • Norfolk, Virginia, United States
        • Teva Investigational Site 164
      • Richmond, Virginia, United States
        • Teva Investigational Site 54
    • Washington
      • Seattle, Washington, United States
        • Teva Investigational Site 42
      • Spokane, Washington, United States
        • Teva Investigational Site 150
      • Vancouver, Washington, United States
        • Teva Investigational Site 163
    • West Virginia
      • Morgantown, West Virginia, United States
        • Teva Investigational Site 66
    • Wisconsin
      • Madison, Wisconsin, United States
        • Teva Investigational Site 41
      • Wausau, Wisconsin, United States
        • Teva Investigational Site 62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Histopathologic confirmation of one of the following cluster of differentiation antigen 20 positive (CD20+) B-cell non-Hodgkin's lymphomas (tissue diagnostic procedures must be performed within 6 months of study entry and with biopsy material available for review):

    • follicular lymphoma (NCI CTCAE grade 1 or 2)
    • immunoplasmacytoma/immunocytoma (Waldenstrom's macroglobulinemia)
    • splenic marginal zone B-cell lymphoma
    • extra-nodal marginal zone lymphoma of mucosa-associated lymphoid tumor (MALT) type
    • nodal marginal zone B-cell lymphoma
    • mantle cell lymphoma

  • Meets one of the following need-for-treatment criteria (with the exception of mantle cell lymphoma for which treatment is indicated):

    • presence of at least one of the following B-symptoms:

      1. fever (>38ºC) of unclear etiology
      2. night sweats
      3. weight loss of greater than 10% within the prior 6 months
    • large tumor mass (bulky disease)
    • presence of lymphoma-related complications, including narrowing of ureters or bile ducts, tumor-related compression of a vital organ, lymphoma-induced pain, cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or ascites
    • hyperviscosity syndrome due to monoclonal gammopathy
  • CD20+ B cells in lymph node biopsy or other lymphoma pathology specimen.
  • No prior treatment (patients on "watch and wait" may enter the study if a recent biopsy [obtained within the last 6 months] is available)

  • Adequate hematologic function (unless abnormalities related to lymphoma infiltration of the bone marrow or hypersplenism due to lymphoma) as follows:

    • hemoglobin of >= 10.0 g/dL
    • absolute neutrophil count (ANC) >=1.5*10^9/L
    • platelet count >=100*10^9/L
  • Bidimensionally measurable disease (field not previously radiated)
  • Able to provide written informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status <=2
  • Estimated life expectancy >=6 months
  • Serum creatinine of <=2.0 mg/dL or creatinine clearance >=50 mL/min
  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5*upper limit of normal (ULN), and alkaline phosphatase and total bilirubin within normal limits
  • Left ventricular ejection fraction (LVEF) >= 50% by multiple gated acquisition scan (MUGA) or cardiac echocardiogram (ECHO), prior for any patient to be treated with R-CHOP
  • A medically accepted method of contraception to be used by women of childbearing potential (not surgically sterile or at least 12 months naturally postmenopausal)
  • Men capable of producing offspring and not surgically sterile must practice abstinence or use a barrier method of birth control.

Key Exclusion Criteria:

  • Chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), or grade 3 follicular lymphoma
  • Transformed disease (bone marrow blasts are permitted; however, transformed disease indicating leukemic involvement is not permitted)
  • Central nervous system (CNS) lymphomatous involvement or leptomeningeal lymphoma
  • Prior radiation for NHL, except for a single course of locally delimited radiation therapy with a radiation field not exceeding 2 adjacent lymph node regions
  • Active malignancy, other than NHL, within the past 3 years except for localized prostate cancer treated with hormone therapy, cervical carcinoma in situ, breast cancer in situ, or non-melanoma skin cancer following definitive treatment
  • New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias or unstable angina, electrocardiograph (ECG) evidence of active ischemia or active conduction system abnormalities, or myocardial infarction within the last 6 months (prior to study entry, ECG abnormalities at screening must be documented by the investigator as not medically relevant)
  • Known human immunodeficiency virus (HIV) positivity
  • Active hepatitis B or hepatitis C infection (hepatitis B surface antigen testing required)
  • Women who are pregnant or lactating
  • Corticosteroids for treatment of lymphoma within 28 days of study entry Chronically administered low-dose corticosteroids (e.g., prednisone ≤20 mg/day) for indications other than lymphoma or lymphoma-related complications are permitted
  • Any serious uncontrolled, medical or psychological disorder that would impair the ability of the patient to receive therapy
  • Any condition which places the patient at unacceptable risk or confounds the ability of the investigators to interpret study data
  • Any other investigational agent within 28 days of study entry
  • Known hypersensitivity to bendamustine, mannitol, or other study-related drugs
  • Ann Arbor stage I disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: rituximab
Other Names:
  • Rituxan
  • MabThera
  • Zytux
Drug: bendamustine
Other Names:
  • Treanda
  • SDX-105
  • Levact
  • Ribomustin
  • Treakisym
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
Drug: cyclophosphamide
Other Names:
  • Cytoxan
  • Endoxan
  • Neosar
  • Revimmune
  • Procytox
Drug: prednisone
Drug: rituximab
Other Names:
  • Rituxan
  • MabThera
  • Zytux
Drug: doxorubicin
Other Names:
  • Adriamycin
Drug: vincristine
Other Names:
  • Oncovin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
6 to 8 21 or 28-day cycles (18-32 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Overall Response at End of Treatment Period
Time Frame: 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.
6 to 8 21 or 28-day cycles (18-32 weeks)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to AEs at End of Treatment Period
Time Frame: 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.
32 weeks
Worst Overall Common Terminology Criteria for Adverse Events (CTCAE) Grades for Serum Chemistry Laboratory Test Results
Time Frame: 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).
32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
Worst Overall CTCAE Grade for Hematology Laboratory Test Results
Time Frame: 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).
32 weeks (conducted at screening, Day 1 of each cycle, weekly during treatment, and at the end-of-treatment visit)
Clinically Significant Abnormal Vital Signs
Time Frame: 32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
Potentially Clinically Significant Abnormal Weight
Time Frame: 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.
Baseline, Week 32
Eastern Cooperative Oncology Group (ECOG) Performance Status at the End of Treatment Period
Time Frame: 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).
Week 32
Therapeutic Classification of Prior Medications
Time Frame: prior to start of treatment
prior to start of treatment
Therapeutic Classification of Concomitant Medications
Time Frame: 32 weeks
32 weeks
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)
Time Frame: Day 1 (prior to treatment), 32 weeks
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.
Day 1 (prior to treatment), 32 weeks
Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period
Time Frame: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment 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
Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period
Kaplan-Meier Estimate for Progression-free Survival (PFS)
Time Frame: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
PFS was defined as the time from randomization to disease progression or relapse, or death from any cause, whichever occurred first.
Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
Kaplan-Meier Estimate for Event-free Survival (EFS)
Time Frame: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)

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.
Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
Kaplan-Meier Estimate for Duration of Response (DOR)
Time Frame: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
DOR was defined as the time from first response (CR or PR) to disease progression or relapse, or death due to any cause.
Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
Overall Survival (OS)
Time Frame: Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
OS was defined as the time from randomization to death from any cause.
Day 1 up to 5.6 years (Treatment Period + Long-Term Follow-up Period)
Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period
Time Frame: Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment 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.
Treatment Period: 18-32 weeks Long-Term Follow-up Period: up to 5 years after the Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C18083/3064/NL/MN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Hodgkin's Lymphoma

Clinical Trials on cyclophosphamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings