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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03274492




Registration number
NCT03274492
Ethics application status
Date submitted
5/09/2017
Date registered
7/09/2017
Date last updated
5/07/2024

Titles & IDs
Public title
A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
Scientific title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma
Secondary ID [1] 0 0
2017-002023-21
Secondary ID [2] 0 0
GO39942
Universal Trial Number (UTN)
Trial acronym
POLARIX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Polatuzumab Vedotin
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Vincristine Placebo
Treatment: Drugs - Prednisone
Treatment: Drugs - Polatuzumab vedotin Placebo

Experimental: R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin - Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m\^2) IV, cyclophosphamide 750 mg/m\^2 IV, and doxorubicin 50 mg/m\^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8.

Placebo comparator: R-CHOP plus Polatuzumab Vedotin Placebo - Participants will receive placebo for polatuzumab vedotin, rituximab 375 mg/m\^2 IV, cyclophosphamide 750 mg/m\^2 IV, doxorubicin 50 mg/m\^2 IV, and vincristine 1.4 mg/m\^2 IV (maximum 2 milligrams per dose \[mg/dose\]) on Day 1 and prednisone 100 mg/day PO on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8.


Treatment: Drugs: Polatuzumab Vedotin
Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Vincristine Placebo
Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Polatuzumab vedotin Placebo
Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [1] 0 0
From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 38 months)
Secondary outcome [1] 0 0
Percentage of Participants With Complete Response (CR) as Assessed by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Secondary outcome [2] 0 0
Event-Free Survival-Efficacy (EFSeff) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [2] 0 0
From randomization to first occurrence of disease progression/relapse;or death from any cause;or other primary efficacy reason that leads to initiation of any non-protocol specified antilymphoma treatment(NALT);or residual disease(up to approx 65 months)
Secondary outcome [3] 0 0
Percentage of Participants Who are Progression Free as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [3] 0 0
24 months after enrollment (up to approximately 65 months)
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
From randomization until death from any cause (up to approximately 65 months)
Secondary outcome [5] 0 0
Percentage of Participants With CR as Assessed by FDG-PET by Investigator
Timepoint [5] 0 0
End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days] [up to Week 32])
Secondary outcome [6] 0 0
Disease-Free Survival (DFS) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [6] 0 0
From the date of first occurrence of a documented CR to the date of relapse or death from any cause (up to approximately 65 months)
Secondary outcome [7] 0 0
Duration of Response as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [7] 0 0
From the date of first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause (up to approximately 65 months)
Secondary outcome [8] 0 0
Event-Free Survival-All Causes (EFSall) as Assessed by the Investigator, Using the Lugano Response Criteria for Malignant Lymphoma
Timepoint [8] 0 0
From randomization to disease progression or relapse, or death from any cause, or initiation of any NALT (up to approximately 65 months)
Secondary outcome [9] 0 0
Time to Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) Physical Functioning and Fatigue
Timepoint [9] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); treatment completion visit (TCV)/early treatment termination visit (ETTV) (up to approximately 32 weeks); post-treatment follow-up (FU) visit (up to approximately 65 months)
Secondary outcome [10] 0 0
Time to Deterioration in Functional Assessment of Cancer Therapy-Lymphoma Lymphoma Subscale (FACT-Lym LymS)
Timepoint [10] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [11] 0 0
Percentage of Participants Achieving Meaningful Improvement in EORTC QLQ-C30 Physical Functioning and Fatigue
Timepoint [11] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [12] 0 0
Percentage of Participants Achieving Meaningful Improvement in FACT-Lym LymS
Timepoint [12] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [13] 0 0
EORTC QLQ-C30 Treatment-Related Symptoms Score
Timepoint [13] 0 0
Day 1 of Cycles 1, 2, 3 and 5 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [14] 0 0
Functional Assessment of Cancer Treatment/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Peripheral Neuropathy Score
Timepoint [14] 0 0
Day 1 of Cycles 1-8 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [15] 0 0
Percentage of Participants With adverse Events (AEs)
Timepoint [15] 0 0
From randomization to the end of study (up to approximately 65 months)
Secondary outcome [16] 0 0
Serum Concentration of Total Polatuzumab Vedotin
Timepoint [16] 0 0
Pre-infusion (0 hour [hr]), 0.5 hr post-infusion (infusion duration=90 minutes [min]) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [17] 0 0
Plasma Concentration of Polatuzumab Vedotin Conjugate (Antibody-Conjugated Mono-Methyl Auristatin E [acMMAE])
Timepoint [17] 0 0
0.5 hr post-infusion (infusion duration=90 min) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [18] 0 0
Plasma Concentration of Polatuzumab Vedotin Unconjugated MMAE
Timepoint [18] 0 0
0.5 hr post-infusion (infusion duration=90 min) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)
Secondary outcome [19] 0 0
Percentage of Participants With Anti-Drug Antibody (ADA) to Polatuzumab Vedotin
Timepoint [19] 0 0
Pre-infusion (0 hr) on Day 1 of Cycle 1 and 4 (Cycle length=21 days); TCV/ETTV (up to approximately 32 weeks); post-treatment FU visit (up to approximately 65 months)

Eligibility
Key inclusion criteria
* Previously untreated participants with cluster of differentiation 20 (CD20)-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type; T-cell/histiocyte-rich large B-cell lymphoma; Epstein-Barr virus-positive DLBCL, NOS; anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma; human herpesvirus-8 (HHV8)-positive DLBCL, NOS; High-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma); High-grade B-cell lymphoma, NOS
* Availability of archival or freshly collected tumor tissue before study enrolment
* International Prognostic Index (IPI) score of 2-5
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life expectancy greater than or equal to (>/=)12 months
* Left ventricular ejection fraction (LVEF) >/= 50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
* Adequate hematologic function
* Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs.
* Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
* Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
* Prior organ transplantation
* Current Grade greater than (>) 1 peripheral neuropathy by clinical examination
* Demyelinating form of Charcot-Marie-Tooth disease
* History of indolent lymphoma
* History of follicular lymphoma grade 3B
* B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma)
* Primary mediastinal (thymic) large B-cell lymphoma
* Burkitt lymphoma
* Prior treatment with cytotoxic drugs within 5 years of screening for any condition (example [e.g.], cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody
* Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
* Prior therapy for DLBCL, with the exception of nodal biopsy
* Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
* Participants with central nervous system (CNS) lymphoma (primary or secondary involvement), primary effusion DLBCL, and primary cutaneous DLBCL
* Vaccination with live vaccines within 28 days prior to the start of Cycle 1
* Any investigational therapy within 28 days prior to the start of Cycle 1
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
* Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle 1
* Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
* Prior radiotherapy to the mediastinal/pericardial region
* Participants with suspected active or latent tuberculosis
* Positive test results for chronic hepatitis B and hepatitis C infection
* Known history of human immunodeficiency virus (HIV) seropositive status
* Positive results for the human T-lymphotrophic 1 virus (HTLV-1)
* Participants with a history of progressive multifocal leukoencephalopathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/07/2024
Actual
Sample size
Target
Accrual to date
Final
1000
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Prince of Wales Hospital; Haematology - Randwick
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
Westmead Hospital; Outpatient Pharmacy University Clinic - Westmead
Recruitment hospital [6] 0 0
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology - Woolloongabba
Recruitment hospital [7] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [8] 0 0
The University of Adelaide - The Queen Elizabeth Hospital (TQEH) - Woodville South
Recruitment hospital [9] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [10] 0 0
Austin Hospital; Cancer Clinical Trials Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [8] 0 0
5011 - Woodville South
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
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Kentucky
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United States of America
State/province [8] 0 0
Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Michigan
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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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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Austria
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Innsbruck
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Austria
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Krems
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Austria
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Salzburg
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Austria
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Wien
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Belgium
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Gent
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Belgium
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Haine-Saint-Paul
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Belgium
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Mont-godinne
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Brazil
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PR
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Brazil
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RS
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Brazil
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Beijing City
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Beijing
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Fuzhou City
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Hangzhou
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China
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Nanjing City
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China
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Nanjing
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China
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Shanghai City
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China
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Tianjin City
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China
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Tianjin
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China
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Wuhan City
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China
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Zhengzhou
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Ostrava - Poruba
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Czechia
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Prague
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Amiens
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Angers
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Bayonne
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Besancon
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Bordeaux
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Caen
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CHAMBERY Cedex
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Creteil
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Dijon
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Grenoble
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La Roche Sur Yon
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La Tronche
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Le Mans Cedex 02
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Lille
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Limoges
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Lyon
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Montpellier
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Nantes
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Nice
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Nimes
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France
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Paris
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France
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Perpignan
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France
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Pessac
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France
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Pierre Benite
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France
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Poitiers
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France
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Quimper Cedex
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France
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Rennes
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France
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Rouen
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France
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St Brieuc
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France
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St Priest en Jarez
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France
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Strasbourg
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France
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Toulouse
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France
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Tours
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France
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Vandoeuvre Les Nancy
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France
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Vannes Cedex
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France
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Villejuif
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Germany
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Berlin
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Germany
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Dessau-Roßlau
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Germany
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Essen
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Germany
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Halle
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Germany
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Heidelberg
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Germany
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Koblenz
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Germany
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München
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Germany
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Münster
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Hong Kong
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Hong Kong
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Hong Kong
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Kowloon
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Italy
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Abruzzo
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Italy
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Emilia-Romagna
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Piemonte
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Tochigi
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Japan
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Tokyo
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Korea, Republic of
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Busan
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
Country [125] 0 0
Korea, Republic of
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Southhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03274492