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

Phase 3

Completed

Conditions: Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: bendamustine
Drug: rituximab
Drug: vincristine
Drug: prednisone
Drug: cyclophosphamide
Drug: doxorubicin

Registration Number: NCT00877006

Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 447

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bendamustine and Rituximab (BR)	bendamustine	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
Bendamustine and Rituximab (BR)	rituximab	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
R-CHOP/R-CVP	vincristine	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
R-CHOP/R-CVP	rituximab	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
R-CHOP/R-CVP	prednisone	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
R-CHOP/R-CVP	cyclophosphamide	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
R-CHOP/R-CVP	doxorubicin	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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).
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.
Clinically Significant Abnormal Vital Signs	32 weeks (conducted at screening, Day 1 of each cycle, and end-of-treatment visit)
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.
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).
Therapeutic Classification of Concomitant Medications	32 weeks
Kaplan-Meier Estimate for Progression-free Survival (PFS)	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.
Therapeutic Classification of Prior Medications	prior to start of treatment
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)	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.
Participants With Disease Progression, Relapse or Death At the End of the Treatment Period or the Long-Term Follow-up Period	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
Kaplan-Meier Estimate for Event-free Survival (EFS)	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.
Kaplan-Meier Estimate for Duration of Response (DOR)	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.
Overall Survival (OS)	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.
Participants Who Died At the End of the Treatment Period or the Long-Term Follow-up Period	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.

Trial Locations

Locations (128): Teva Investigational Site 52
🇺🇸
Fountain Valley, California, United States
Teva Investigational Site 72
🇺🇸
Augusta, Georgia, United States
Teva Investigational Site 48
🇺🇸
Chicago, Illinois, United States
Teva Investigational Site 162
🇺🇸
Columbia, Missouri, United States
Teva Investigational Site 13
🇺🇸
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 71
🇺🇸
Columbia, South Carolina, United States
Teva Investigational Site 167
🇺🇸
Little Rock, Arkansas, United States
Teva Investigational Site 11
🇺🇸
Corona, California, United States
Teva Investigational Site 21
🇺🇸
Fountain Valley, California, United States
Teva Investigational Site 64
🇺🇸
Fullerton, California, United States
Teva Investigational Site 40
🇺🇸
Los Angeles, California, United States
Teva Investigational Site 53
🇺🇸
Los Angeles, California, United States
Teva Investigational Site 5
🇺🇸
Fort Collins, Colorado, United States
Teva Investigational Site 37
🇺🇸
Norwalk, Connecticut, United States
Teva Investigational Site 67
🇺🇸
Southington, Connecticut, United States
Teva Investigational Site 58
🇺🇸
Fort Myers, Florida, United States
Teva Investigational Site 65
🇺🇸
Lake Worth, Florida, United States
Teva Investigational Site 23
🇺🇸
Jacksonville, Florida, United States
Teva Investigational Site 38
🇺🇸
Hollywood, Florida, United States
Teva Investigational Site 50
🇺🇸
Columbus, Georgia, United States
Teva Investigational Site 49
🇺🇸
Centralia, Illinois, United States
Teva Investigational Site 73
🇺🇸
Macon, Georgia, United States
Teva Investigational Site 9
🇺🇸
Chicago, Illinois, United States
Teva Investigational Site 14
🇺🇸
Normal, Illinois, United States
Teva Investigational Site 24
🇺🇸
Beech Grove, Indiana, United States
Teva Investigational Site 31
🇺🇸
Iowa City, Iowa, United States
Teva Investigational Site 63
🇺🇸
Waterloo, Iowa, United States
Teva Investigational Site 43
🇺🇸
Augusta, Maine, United States
Teva Investigational Site 33
🇺🇸
Lexington, Kentucky, United States
Teva Investigational Site 19
🇺🇸
Shreveport, Louisiana, United States
Teva Investigational Site 22
🇺🇸
Duluth, Minnesota, United States
Teva Investigational Site 4
🇺🇸
Saint Louis Park, Minnesota, United States
Teva Investigational Site 74
🇺🇸
Lowell, Massachusetts, United States
Teva Investigational Site 29
🇺🇸
Morristown, New Jersey, United States
Teva Investigational Site 46
🇺🇸
Albuquerque, New Mexico, United States
Teva Investigational Site 10
🇺🇸
Syracuse, New York, United States
Teva Investigational Site 39
🇺🇸
Fargo, North Dakota, United States
Teva Investigational Site 17
🇺🇸
Charlotte, North Carolina, United States
Teva Investigational Site 153
🇺🇸
Springfield, Oregon, United States
Teva Investigational Site 3
🇺🇸
Philadelphia, Pennsylvania, United States
Teva Investigational Site 28
🇺🇸
Cleveland, Ohio, United States
Teva Investigational Site 59
🇺🇸
Bethlehem, Pennsylvania, United States
Teva Investigational Site 44
🇺🇸
Danville, Pennsylvania, United States
Teva Investigational Site 7
🇺🇸
Pottstown, Pennsylvania, United States
Teva Investigational Site 154
🇺🇸
Arlington, Texas, United States
Teva Investigational Site 158
🇺🇸
Arlington, Texas, United States
Teva Investigational Site 6
🇺🇸
El Paso, Texas, United States
Teva Investigational Site 161
🇺🇸
Fort Worth, Texas, United States
Teva Investigational Site 18
🇺🇸
Abingdon, Virginia, United States
Teva Investigational Site 166
🇺🇸
Sugar Land, Texas, United States
Teva Investigational Site 164
🇺🇸
Norfolk, Virginia, United States
Teva Investigational Site 42
🇺🇸
Seattle, Washington, United States
Teva Investigational Site 150
🇺🇸
Spokane, Washington, United States
Teva Investigational Site 163
🇺🇸
Vancouver, Washington, United States
Teva Investigational Site 66
🇺🇸
Morgantown, West Virginia, United States
Teva Investigational Site 305
🇦🇺
Concord, Australia
Teva Investigational Site 62
🇺🇸
Wausau, Wisconsin, United States
Teva Investigational Site 41
🇺🇸
Madison, Wisconsin, United States
Teva Investigational Site 308
🇦🇺
East Melbourne, Australia
Teva Investigational Site 317
🇦🇺
Douglas, Australia
Teva Investigational Site 310
🇦🇺
Fitzroy, Australia
Teva Investigational Site 311
🇦🇺
Fitzroy, Australia
Teva Investigational Site 301
🇦🇺
Garran, Australia
Teva Investigational Site 312
🇦🇺
Kurralta Park, Australia
Teva Investigational Site 304
🇦🇺
Hobart, Australia
Teva Investigational Site 318
🇦🇺
Parkville, Australia
Teva Investigational Site 314
🇦🇺
Wodonga, Australia
Teva Investigational Site 307
🇦🇺
Melbourne, Australia
Teva Investigational Site 300
🇦🇺
South Brisbane, Australia
Teva Investigational Site 303
🇦🇺
Westmead, Australia
Teva Investigational Site 503
🇧🇷
Barretos, Brazil
Teva Investigational Site 313
🇦🇺
Woodville, Australia
Teva Investigational Site 309
🇦🇺
Woolloongabba, Australia
Teva Investigational Site 511
🇧🇷
Rio De Janeiro, Brazil
Teva Investigational Site 504
🇧🇷
Brasilia, Brazil
Teva Investigational Site 506
🇧🇷
Curitiba, Brazil
Teva Investigational Site 500
🇧🇷
Santo Andre, Brazil
Teva Investigational Site 505
🇧🇷
Goiânia, Brazil
Teva Investigational Site 502
🇧🇷
Jau, Brazil
Teva Investigational Site 507
🇧🇷
Porto Alegre, Brazil
Teva Investigational Site 509
🇧🇷
Lajeado, Brazil
Teva Investigational Site 508
🇧🇷
Porto Alegre, Brazil
Teva Investigational Site 501
🇧🇷
Sao Paulo, Brazil
Teva Investigational Site 202
🇨🇦
Barrie, Canada
Teva Investigational Site 206
🇨🇦
Calgary, Canada
Teva Investigational Site 203
🇨🇦
Vancouver, Canada
Teva Investigational Site 602
🇲🇽
Aguascalientes, Mexico
Teva Investigational Site 401
🇳🇿
Auckland, New Zealand
Teva Investigational Site 603
🇲🇽
Hermosillo, Mexico
Teva Investigational Site 600
🇲🇽
Monterrey, Mexico
Teva Investigational Site 601
🇲🇽
Monterrey, Mexico
Teva Investigational Site 405
🇳🇿
Auckland, New Zealand
Teva Investigational Site 400
🇳🇿
Christchurch, New Zealand
Teva Investigational Site 402
🇳🇿
Newtown, New Zealand
Teva Investigational Site 404
🇳🇿
Palmerston North, New Zealand
Teva Investigational Site 700
🇵🇪
Lima, Peru
Teva Investigational Site 701
🇵🇪
Lima, Peru
Teva Investigational Site 403
🇳🇿
Takapuna, New Zealand
Teva Investigational Site 702
🇵🇪
Miraflores, Peru
Teva Investigational Site 47
🇺🇸
Wichita, Kansas, United States
Teva Investigational Site 315
🇦🇺
Perth, Western Australia, Australia
Teva Investigational Site 57
🇺🇸
San Diego, California, United States
Teva Investigational Site 156
🇺🇸
Miami, Florida, United States
Teva Investigational Site 152
🇺🇸
Indianapolis, Indiana, United States
Teva Investigational Site 34
🇺🇸
Cincinnati, Ohio, United States
Teva Investigational Site 60
🇺🇸
Cincinnati, Ohio, United States
Teva Investigational Site 2
🇺🇸
Salt Lake City, Utah, United States
Teva Investigational Site 151
🇺🇸
Durham, North Carolina, United States
Teva Investigational Site 159
🇺🇸
San Antonio, Texas, United States
Teva Investigational Site 30
🇺🇸
Nashville, Tennessee, United States
Teva Investigational Site 200
🇨🇦
Halifax, Canada
Teva Investigational Site 201
🇨🇦
Ottawa, Canada
Teva Investigational Site 204
🇨🇦
Winnipeg, Canada
Teva Investigational Site 155
🇺🇸
Denver, Colorado, United States
Teva Investigational Site 15
🇺🇸
Aurora, Colorado, United States
Teva Investigational Site 316
🇦🇺
Geelong, Australia
Teva Investigational Site 165
🇺🇸
Tucson, Arizona, United States
Teva Investigational Site 704
🇵🇪
Lima, Peru
Teva Investigational Site 56
🇺🇸
Chattanooga, Tennessee, United States
Teva Investigational Site 70
🇺🇸
New Britain, Connecticut, United States
Teva Investigational Site 703
🇵🇪
Miraflores, Peru
Teva Investigational Site 157
🇺🇸
Kansas City, Missouri, United States
Teva Investigational Site 160
🇺🇸
Orlando, Florida, United States
Teva Investigational Site 68
🇺🇸
Orlando, Florida, United States
Teva Investigational Site 25
🇺🇸
Charleston, South Carolina, United States
Teva Investigational Site 54
🇺🇸
Richmond, Virginia, United States
Teva Investigational Site 8
🇺🇸
Rochester, New York, United States
Teva Investigational Site 35
🇺🇸
Charlottesville, Virginia, United States