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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02005471




Registration number
NCT02005471
Ethics application status
Date submitted
4/12/2013
Date registered
9/12/2013

Titles & IDs
Public title
A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Scientific title
A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab
Secondary ID [1] 0 0
2013-002110-12
Secondary ID [2] 0 0
GO28667
Universal Trial Number (UTN)
Trial acronym
MURANO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bendamustine
Treatment: Drugs - Venetoclax
Treatment: Drugs - Rituximab

Active comparator: Bendamustine + Rituximab - Participants will receive bendamustine 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 followed by 500 mg/m\^2 on Day 1 of Cycles 2-6.

Experimental: Venetoclax + Rituximab - Participants will be initially placed on a venetoclax 5 weeks ramp-up period, and will receive an initial dose of 20 milligrams (mg) via tablet orally once daily (QD). Then the dose will be incremented weekly up to a maximum dose of 400 mg. Participants will then continue receiving venetoclax 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards, as directed by the investigator, in combination with rituximab 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 followed by 500 mg/m\^2 on Day 1 of Cycles 2-6.

Experimental: Bendamustine + Rituximab Crossover Substudy - Participants entering the Crossover Substudy will have a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, Participants will receive 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants will continue to take their daily dose of venetoclax during the rituximab cycles. Participants who have not progressed following the completion of the 6 cycles will continue to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 Crossover Day 1 of the Substudy.

Experimental: Venetoclax + Rituximab Re-Treatment - Participants entering the Re-Treatment Substudy will have a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, Participants will receive 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants will continue to take their daily dose of venetoclax during the rituximab cycles. Participants who have not progressed following the completion of the 6 cycles will continue to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 Re-Treatment Day 1 of the Substudy.


Treatment: Drugs: Bendamustine
Bendamustine will be administered at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.

Treatment: Drugs: Venetoclax
Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first.

R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy.

Treatment: Drugs: Rituximab
Rituximab will be administered at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.

R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death
Timepoint [1] 0 0
Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
Primary outcome [2] 0 0
Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines
Timepoint [2] 0 0
Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
Secondary outcome [1] 0 0
Percentage of Participants With PD or Death as Assessed by the Independent Review Committee (IRC) Using Standard iwCLL Guidelines
Timepoint [1] 0 0
Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
Secondary outcome [2] 0 0
PFS as Assessed by the IRC Using Standard iwCLL Guidelines
Timepoint [2] 0 0
Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
Secondary outcome [3] 0 0
Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test
Timepoint [3] 0 0
Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
Secondary outcome [4] 0 0
PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
Timepoint [4] 0 0
Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)
Secondary outcome [5] 0 0
Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
Timepoint [5] 0 0
Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
Secondary outcome [6] 0 0
PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test
Timepoint [6] 0 0
Baseline up to PD or death, whichever occurred first (up to approximately 3 years)
Secondary outcome [7] 0 0
Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines
Timepoint [7] 0 0
Baseline up to approximately 8 years 5 months
Secondary outcome [8] 0 0
Percentage of Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the IRC Using iwCLL Guidelines
Timepoint [8] 0 0
Baseline up to last FUV (up to approximately 3 years)
Secondary outcome [9] 0 0
Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the Investigator Using iwCLL Guidelines
Timepoint [9] 0 0
End of combination treatment response (EoCTR) visit (8 to 12 weeks after Cycle [C] 6 Day [1]); Cycle length = 28 days
Secondary outcome [10] 0 0
Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the IRC Using iwCLL Guidelines
Timepoint [10] 0 0
EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days
Secondary outcome [11] 0 0
Percentage of Participants Who Died
Timepoint [11] 0 0
Baseline up to approximately 8 years 5 months
Secondary outcome [12] 0 0
Overall Survival (OS)
Timepoint [12] 0 0
Baseline up to approximately 8 years 5 months
Secondary outcome [13] 0 0
Percentage of Participants With PD/Relapse, Start of a New Anti-Chronic Lymphocytic Leukemia (CLL) Therapy, or Death as Assessed by the Investigator Using iwCLL Guidelines
Timepoint [13] 0 0
Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (approximately 8 years 5 months)
Secondary outcome [14] 0 0
Event-Free Survival (EFS) as Assessed by the Investigator Using iwCLL Guidelines
Timepoint [14] 0 0
Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (approximately 8 years 5 months)
Secondary outcome [15] 0 0
Percentage of Participants With PD or Death Among Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the Investigator Using iwCLL Guidelines
Timepoint [15] 0 0
From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
Secondary outcome [16] 0 0
Duration of Responses (DOR) as Assessed by the Investigator Using iwCLL Guidelines
Timepoint [16] 0 0
From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
Secondary outcome [17] 0 0
Percentage of Participants With Start of New Anti-CLL Treatment or Death as Assessed by the Investigator
Timepoint [17] 0 0
Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 8 years 5 months)
Secondary outcome [18] 0 0
Time to New Anti-CLL Treatment (TTNT) as Assessed by the Investigator
Timepoint [18] 0 0
Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 8 years 5 months)
Secondary outcome [19] 0 0
Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood
Timepoint [19] 0 0
EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days
Secondary outcome [20] 0 0
Percentage of Participants With MRD Negativity in Bone Marrow
Timepoint [20] 0 0
EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days
Secondary outcome [21] 0 0
Plasma Venetoclax Concentrations
Timepoint [21] 0 0
Pre-dose (0 hour, anytime before venetoclax administration) and 4 hours post-dose on D1 of Cycles 1 and 4; Cycle length = 28 days
Secondary outcome [22] 0 0
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores
Timepoint [22] 0 0
Baseline, Days 1, 8, and 15 of Cycles 1, 2, and 3; Cycle length = 28 days
Secondary outcome [23] 0 0
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score
Timepoint [23] 0 0
Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days
Secondary outcome [24] 0 0
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score
Timepoint [24] 0 0
Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days
Secondary outcome [25] 0 0
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [25] 0 0
From signing of informed consent form up to approximately 8 years 5 months
Secondary outcome [26] 0 0
Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs)
Timepoint [26] 0 0
From signing of informed consent form up to approximately 8 years 5 months

Eligibility
Key inclusion criteria
* Diagnosis of CLL per diagnostic criteria for relapsed or refractory CLL per the international workshop on chronic lymphocytic leukemia (iwCLL) guidelines
* Previously treated with 1-3 lines of therapy (example: completed greater than or equal to [>/=] 2 treatment cycles per therapy), including at least one standard chemotherapy-containing regimen
* Participants previously treated with bendamustine only if their duration of response was >/= 24 months
* Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 1
* Adequate bone marrow function
* Adequate renal and hepatic function
* Participants must use effective birth control throughout study until at least 30 days after study treatment or 1 year after rituximab treatment, whichever is later; female participants must not be pregnant or breast-feeding
* For participants with the 17p deletion, previously treated with 1-3 lines of therapy, including at least one prior standard chemotherapy-containing regimen or at least one prior alemtuzumab-containing therapy

Inclusion Criteria R/C Substudy:

* Participants randomized to Arm A or Arm B with a confirmed disease progression of CLL per iwCLL criteria
* Participants who have not received new anti-CLL therapy following disease progression in Arm A or Arm B
* Adequate renal and hepatic function per laboratory reference range
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Transformation of CLL to aggressive non-Hodgkin lymphoma or central nervous system (CNS) involvement by CLL
* Undergone an allogenic stem cell transplant
* A history of significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular or hepatic disease
* Hepatitis B or C or known human immunodeficiency virus (HIV) positive
* Receiving warfarin treatment
* Received an anti-CLL monoclonal antibody within 8 weeks prior to the first dose of study drug
* Received any anti-cancer or investigational therapy within 28 days prior to the first dose of study drug or has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of any previous therapy
* Received cytochrome P450 3A4 (CYP3A4) inhibitors (such as fluconazole, ketoconazole and clarithromycin) or inducers (such as rifampin, carbamazapine, phenytoin, St. John's Wort) within 7 days prior to the first dose of venetoclax
* History of prior venetoclax treatment
* Participants with another cancer, history of another cancer considered uncured on in complete remission for <5 years, or currently under treatment for another suspected cancer except non-melanoma skin cancer or carcinoma in situ of the cervix that has been treated or excised and is considered resolved
* Malabsorption syndrome or other condition that precludes enteral route of administration
* Other clinically significant uncontrolled condition(s) including, but not limited to, systemic infection (viral, bacterial or fungal)
* Vaccination with a live vaccine within 28 days prior to randomization
* Consumed grapefruit or grapefruit products, seville oranges (including marmalade containing seville oranges), or star fruit within 3 days prior to the first dose of study treatment
* A cardiovascular disability status of New York Heart Association Class >/=3. Class 3 is defined as cardiac disease in which participants are comfortable at rest but have marked limitation of physical activity due to fatigue, palpitations, dyspnea, or anginal pain
* Major surgery within 30 days prior to the first dose of study treatment
* A participant who is pregnant or breastfeeding
* Known allergy to both xanthine oxidase inhibitors and rasburicase

Exclusion Criteria R/C Substudy:

* Transformation of CLL to aggressive NHL (e.g., Richter's transformation, prolymphocytic leukemia, or DLBCL) or CNS involvement by CLL
* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal)
* Development of other malignancy since enrollment into the study, with the exception of curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
* History of severe (i.e., requiring permanent discontinuation of prior rituximab therapy) prior allergic or anaphylactic reactions to rituximab
* Known HIV positivity
* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HbsAg] serology)
* Positive test results for hepatitis C virus (HCV; HCV antibody serology testing)
* Requires the use of warfarin (due to potential drug interactions that may potentially increase the exposure of warfarin)
* Has not recovered to less than Grade 2 clinically significant adverse effect(s)/toxicity(ies) of any previous therapy
* Received potent CYP3A4 inhibitors (such as fluconazole, ketoconazole, and clarithromycin) within 7 days prior to the first dose of study treatment
* Received potent CYP3A4 inducers (such as rifampin, carbamazepine, phenytoin, St. John's wort) within 7 days prior to the first dose of study treatment
* Consumed grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study treatment
* A cardiovascular disability status of New York Heart Association Class >/= 3
* A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect the participants's participation in this study or interpretation of study outcomes
* Major surgery within 30 days prior to the first dose of study treatment
* A participant who is pregnant or breastfeeding
* Malabsorption syndrome or other condition that precludes enteral route of administration
* Known allergy to both xanthine oxidase inhibitors and rasburicase
* Vaccination with a live vaccine within 28 days prior to randomization

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2022
Sample size
Target
Accrual to date
Final
389
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
St George Hospital - Kogarah, New South Wales
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Frankston Hospital - Frankston
Recruitment hospital [9] 0 0
Monash Medical Centre; Haematology - Melbourne
Recruitment hospital [10] 0 0
Slade Health Pharmacy - Mount Waverley
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Center - North Melbourne
Recruitment hospital [12] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [13] 0 0
The Perth Blood Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2217 - Kogarah, New South Wales
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3168 - Melbourne
Recruitment postcode(s) [10] 0 0
3149 - Mount Waverley
Recruitment postcode(s) [11] 0 0
3051 - North Melbourne
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
Austria
State/province [5] 0 0
Innsbruck
Country [6] 0 0
Austria
State/province [6] 0 0
Salzburg
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Belgium
State/province [8] 0 0
Antwerpen
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Kortrijk
Country [11] 0 0
Belgium
State/province [11] 0 0
Leuven
Country [12] 0 0
Belgium
State/province [12] 0 0
Mont-godinne
Country [13] 0 0
Belgium
State/province [13] 0 0
Roeselare
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Canada
State/province [17] 0 0
Saskatchewan
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno
Country [19] 0 0
Czechia
State/province [19] 0 0
Hradec Kralove
Country [20] 0 0
Czechia
State/province [20] 0 0
Olomouc
Country [21] 0 0
Czechia
State/province [21] 0 0
Ostrava - Poruba
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 2
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha
Country [24] 0 0
Denmark
State/province [24] 0 0
Herlev
Country [25] 0 0
Denmark
State/province [25] 0 0
København Ø
Country [26] 0 0
Denmark
State/province [26] 0 0
Odense C
Country [27] 0 0
Denmark
State/province [27] 0 0
Roskilde
Country [28] 0 0
Denmark
State/province [28] 0 0
Vejle
Country [29] 0 0
France
State/province [29] 0 0
Brest
Country [30] 0 0
France
State/province [30] 0 0
La Roche sur Yon
Country [31] 0 0
France
State/province [31] 0 0
Lille
Country [32] 0 0
France
State/province [32] 0 0
Montpellier
Country [33] 0 0
France
State/province [33] 0 0
Nantes
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Pierre Benite
Country [36] 0 0
France
State/province [36] 0 0
Poitiers
Country [37] 0 0
France
State/province [37] 0 0
Rennes
Country [38] 0 0
France
State/province [38] 0 0
Rouen
Country [39] 0 0
France
State/province [39] 0 0
Toulouse
Country [40] 0 0
France
State/province [40] 0 0
Tours
Country [41] 0 0
France
State/province [41] 0 0
Vandoeuvre-les-nancy
Country [42] 0 0
Germany
State/province [42] 0 0
Dresden
Country [43] 0 0
Germany
State/province [43] 0 0
Freiburg
Country [44] 0 0
Germany
State/province [44] 0 0
Tübingen
Country [45] 0 0
Hungary
State/province [45] 0 0
Budapest
Country [46] 0 0
Hungary
State/province [46] 0 0
Debrecen
Country [47] 0 0
Hungary
State/province [47] 0 0
Pecs
Country [48] 0 0
Hungary
State/province [48] 0 0
Szeged
Country [49] 0 0
Italy
State/province [49] 0 0
Abruzzo
Country [50] 0 0
Italy
State/province [50] 0 0
Liguria
Country [51] 0 0
Italy
State/province [51] 0 0
Lombardia
Country [52] 0 0
Italy
State/province [52] 0 0
Marche
Country [53] 0 0
Italy
State/province [53] 0 0
Puglia
Country [54] 0 0
Italy
State/province [54] 0 0
Toscana
Country [55] 0 0
Italy
State/province [55] 0 0
Veneto
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seongnam-si
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seoul
Country [58] 0 0
Netherlands
State/province [58] 0 0
Amsterdam
Country [59] 0 0
Netherlands
State/province [59] 0 0
Dordrecht
Country [60] 0 0
Netherlands
State/province [60] 0 0
Enschede
Country [61] 0 0
Netherlands
State/province [61] 0 0
Leiden
Country [62] 0 0
Netherlands
State/province [62] 0 0
Rotterdam
Country [63] 0 0
Netherlands
State/province [63] 0 0
Utrecht
Country [64] 0 0
New Zealand
State/province [64] 0 0
Auckland
Country [65] 0 0
New Zealand
State/province [65] 0 0
Christchurch
Country [66] 0 0
New Zealand
State/province [66] 0 0
Mount Wellington
Country [67] 0 0
Poland
State/province [67] 0 0
Chorzow
Country [68] 0 0
Poland
State/province [68] 0 0
Gdansk
Country [69] 0 0
Poland
State/province [69] 0 0
Lodz
Country [70] 0 0
Poland
State/province [70] 0 0
Opole
Country [71] 0 0
Poland
State/province [71] 0 0
Warszawa
Country [72] 0 0
Poland
State/province [72] 0 0
Zabrze
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Moskovskaja Oblast
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Sankt Petersburg
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Kemerovo
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Omsk
Country [77] 0 0
Spain
State/province [77] 0 0
Navarra
Country [78] 0 0
Spain
State/province [78] 0 0
Barcelona
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Salamanca
Country [81] 0 0
Sweden
State/province [81] 0 0
Lund
Country [82] 0 0
Sweden
State/province [82] 0 0
Uppsala
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taipei
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Bristol
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Manchester
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Southampton
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
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Ethics approval
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Summary
Brief summary
Trial website
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02005471