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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02367040




Registration number
NCT02367040
Ethics application status
Date submitted
12/02/2015
Date registered
20/02/2015

Titles & IDs
Public title
Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
Scientific title
A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Copanlisib in Combination With Rituximab in Patients With Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-3
Secondary ID [1] 0 0
2013-003893-29
Secondary ID [2] 0 0
17067
Universal Trial Number (UTN)
Trial acronym
CHRONOS-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma,Non-Hodgkin 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 - Copanlisib (Aliqopa, BAY80-6946)
Treatment: Drugs - Placebo
Treatment: Drugs - Rituximab

Experimental: Copanlisib + Rituximab - Combination of the Copanlisib and rituximab

Placebo comparator: Placebo + Rituximab - Combination of Copanlisib placebo and rituximab


Treatment: Drugs: Copanlisib (Aliqopa, BAY80-6946)
Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. Dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered before rituximab.

Treatment: Drugs: Placebo
Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Placebo will be administered before rituximab.

Treatment: Drugs: Rituximab
Rituximab dose 375 mg/m2 body surface weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day 1 of Cycles 3, 5, 7 and 9.The solution for IV infusions is obtained after reconstitution of a calculated concentration of 1 to 4 mg/ml rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/ml (0.9%) solution for injection or 5% D-Glucose in water.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) Based on Independent Central Review.
Timepoint [1] 0 0
From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Secondary outcome [2] 0 0
Complete Response Rate (CRR)
Timepoint [2] 0 0
From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Secondary outcome [4] 0 0
Disease Control Rate (DCR)
Timepoint [4] 0 0
From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Secondary outcome [5] 0 0
Time to Progression (TTP)
Timepoint [5] 0 0
From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
From randomization up to approximately 7 years of follow-up.
Secondary outcome [7] 0 0
Time to Deterioration in DRS-P (Disease-Related Symptoms - Physical) of at Least Three Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire.
Timepoint [7] 0 0
From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Secondary outcome [8] 0 0
Time to Improvement in DRS-P (Disease-Related Symptoms - Physical) of at Least 3 Points, as Measured by the Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 (FLymSI-18) Questionnaire.
Timepoint [8] 0 0
From first participant randomization (20-Aug-2015) up to data cut-off date at primary completion (31-Aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-Aug-2022, up to 7 years
Secondary outcome [9] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at Primary Completion Date.
Timepoint [9] 0 0
Up to 30 days after end of treatment with study drug, data reporting cut-off at 5 years from the first participant randomization date
Secondary outcome [10] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) at 2-year Follow-up Cut-off Date.
Timepoint [10] 0 0
Up to 30 days after end of treatment with study drug, data reporting cut-off at 7 years from the first participant randomization date

Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis of Indolent non-Hodgkin's lymphoma (iNHL) in CD20 positive patients, with histological subtype limited to:

* Follicular lymphoma(FL) grade1-2-3a
* Small lymphocytic lymphoma(SLL) with absolute lymphocyte count <5x10*9/L at study entry
* Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
* Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
* Patients must have relapsed (recurrence after complete response or presented progression after partial response) after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)-containing therapy (other previous treatment lines after rituximab are allowed). A previous regimen is defined as one of the following: at least 2 months of single-agent therapy (less than 2 months of therapy is allowed for patients who responded to single-agent rituximab, rituximab biosimilars, or anti-CD20 monoclonal antibody); at least 2 consecutive cycles of polychemotherapy; autologous transplant; radioimmunotherapy. Previous exposure to PI3K is acceptable (except to copanlisib) provided there is no resistance. Patients with prior intolerance to PI3K inhibitors other than copanlisib are eligible.
* Non-WM must have at least one bi-dimensionally measurable lesion (which has not been previously irradiated) according to the Lugano Classification. For patients with splenic MZL (Marginal-zone lymphoma) this requirement may be restricted to splenomegaly alone since that is usually the only manifestation of measurable disease.
* Patients affected by WM who do not have at least one bi-dimensionally measurable lesion in the baseline radiologic assessment must have measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level = 2 x upper limit of normal (ULN) and positive immunofixation test .
* Male or female patients = 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status = 2
* Life expectancy of at least 3 months
* Availability of fresh tumor tissue and/or archival tumor tissue for central pathology(obtained within 5 years of the consent date) at Screening
* Adequate baseline laboratory values collected no more than 7 days before starting study treatment
* Left ventricular ejection fraction = 45%
* Patients must either:

* have had a progression-free and treatment-free interval of at least 12 months after completion of the rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment OR
* be considered unfit to receive chemotherapy on reason of age, concomitant morbidities, and/or residual toxicity from previous treatments, or unwillingness to receive chemotherapy. These patients must also have had a progression-free and treatment-free interval of at least 6 months after completion of the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment. Patients in whom chemotherapy is contraindicated are defined by one of the following features:

* Age = 80 years
* Age < 80 years and at least 1 of the following conditions:

* at least 3 grade 3 CIRS-G comorbidities OR
* at least 1 grade 4 CIRS-G comorbidity (if compatible to participation in the study).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia
* Progression free interval or treatment free interval of less than 12 months since the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody (e.g. obinutuzumab)-containing treatment(including maintenance with these drugs). For patients considered unwilling/unfit to receive chemotherapy : progression free interval or treatment free interval of less than 6 months since the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing treatment (including maintenance with these drugs), as assessed by the investigator
* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function
* Known lymphomatous involvement of the central nervous system
* Patients with HbA1c > 8.5% at Screening
* Known history of human immunodeficiency virus (HIV) infection
* Hepatitis B (HBV) or hepatitis C (HCV). Patients positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti- HCV antibody will be eligible if they are negative for HCV-RNA
* Documented evidence of resistance to prior treatment with idelalisib or other PI3K inhibitors.
* Prior treatment with copanlisib
* Cytomegalovirus (CMV) infection. Patients who are CMV PCR positive at baseline will not be eligible.

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
3/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
Accrual to date
Final
458
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Ballarat
Recruitment hospital [2] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
3350 - Ballarat
Recruitment postcode(s) [2] 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
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Argentina
State/province [10] 0 0
Ciudad Auton. De Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Santa Fe
Country [12] 0 0
Argentina
State/province [12] 0 0
Tucuman
Country [13] 0 0
Argentina
State/province [13] 0 0
Córdoba
Country [14] 0 0
Austria
State/province [14] 0 0
Steiermark
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
Belgium
State/province [16] 0 0
Ottignies
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio Grande Do Sul
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Plovdiv
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sofia
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Varna
Country [22] 0 0
Chile
State/province [22] 0 0
Araucanía
Country [23] 0 0
China
State/province [23] 0 0
Fujian
Country [24] 0 0
China
State/province [24] 0 0
Guangdong
Country [25] 0 0
China
State/province [25] 0 0
Hubei
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China
State/province [26] 0 0
Jiangsu
Country [27] 0 0
China
State/province [27] 0 0
Jiangxi
Country [28] 0 0
China
State/province [28] 0 0
Jilin
Country [29] 0 0
China
State/province [29] 0 0
Liaoning
Country [30] 0 0
China
State/province [30] 0 0
Sichuan
Country [31] 0 0
China
State/province [31] 0 0
Xinjiang
Country [32] 0 0
China
State/province [32] 0 0
Zhejiang
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Chongqing
Country [35] 0 0
China
State/province [35] 0 0
Shanghai
Country [36] 0 0
China
State/province [36] 0 0
Tianjin
Country [37] 0 0
Colombia
State/province [37] 0 0
Antioquia
Country [38] 0 0
Colombia
State/province [38] 0 0
Cundinamarca
Country [39] 0 0
Colombia
State/province [39] 0 0
Córdoba
Country [40] 0 0
Colombia
State/province [40] 0 0
Valle Del Cauca
Country [41] 0 0
France
State/province [41] 0 0
Bayonne
Country [42] 0 0
France
State/province [42] 0 0
Brest
Country [43] 0 0
France
State/province [43] 0 0
Metz Cedex 03
Country [44] 0 0
France
State/province [44] 0 0
Nice Cedex 2
Country [45] 0 0
France
State/province [45] 0 0
Pessac
Country [46] 0 0
France
State/province [46] 0 0
Poitiers
Country [47] 0 0
France
State/province [47] 0 0
Saint-Herblain
Country [48] 0 0
Germany
State/province [48] 0 0
Bayern
Country [49] 0 0
Germany
State/province [49] 0 0
Nordrhein-Westfalen
Country [50] 0 0
Germany
State/province [50] 0 0
Sachsen-Anhalt
Country [51] 0 0
Germany
State/province [51] 0 0
Sachsen
Country [52] 0 0
Germany
State/province [52] 0 0
Berlin
Country [53] 0 0
Greece
State/province [53] 0 0
Athens
Country [54] 0 0
Greece
State/province [54] 0 0
Chaidari
Country [55] 0 0
Greece
State/province [55] 0 0
Patras
Country [56] 0 0
Hong Kong
State/province [56] 0 0
Chai Wan
Country [57] 0 0
Hong Kong
State/province [57] 0 0
Hong Kong
Country [58] 0 0
Hong Kong
State/province [58] 0 0
Shatin
Country [59] 0 0
Hungary
State/province [59] 0 0
Budapest
Country [60] 0 0
Hungary
State/province [60] 0 0
Gyor
Country [61] 0 0
Hungary
State/province [61] 0 0
Kaposvar
Country [62] 0 0
Hungary
State/province [62] 0 0
Pecs
Country [63] 0 0
Hungary
State/province [63] 0 0
Tatabanya
Country [64] 0 0
Ireland
State/province [64] 0 0
Dublin
Country [65] 0 0
Ireland
State/province [65] 0 0
Galway
Country [66] 0 0
Italy
State/province [66] 0 0
Friuli-Venezia Giulia
Country [67] 0 0
Italy
State/province [67] 0 0
Liguria
Country [68] 0 0
Italy
State/province [68] 0 0
Lombardia
Country [69] 0 0
Italy
State/province [69] 0 0
Toscana
Country [70] 0 0
Japan
State/province [70] 0 0
Aichi
Country [71] 0 0
Japan
State/province [71] 0 0
Gunma
Country [72] 0 0
Japan
State/province [72] 0 0
Hyogo
Country [73] 0 0
Japan
State/province [73] 0 0
Kochi
Country [74] 0 0
Japan
State/province [74] 0 0
Miyagi
Country [75] 0 0
Japan
State/province [75] 0 0
Nagasaki
Country [76] 0 0
Japan
State/province [76] 0 0
Okayama
Country [77] 0 0
Japan
State/province [77] 0 0
Osaka
Country [78] 0 0
Japan
State/province [78] 0 0
Shimane
Country [79] 0 0
Japan
State/province [79] 0 0
Tokyo
Country [80] 0 0
Japan
State/province [80] 0 0
Aomori
Country [81] 0 0
Japan
State/province [81] 0 0
Fukuoka
Country [82] 0 0
Japan
State/province [82] 0 0
Kumamoto
Country [83] 0 0
Japan
State/province [83] 0 0
Niigata
Country [84] 0 0
Japan
State/province [84] 0 0
Yamagata
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Seoul Teugbyeolsi
Country [86] 0 0
Korea, Republic of
State/province [86] 0 0
Busan
Country [87] 0 0
Korea, Republic of
State/province [87] 0 0
Hwasun Gun
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Seoul
Country [89] 0 0
Lithuania
State/province [89] 0 0
Kaunas
Country [90] 0 0
Malaysia
State/province [90] 0 0
Cheras
Country [91] 0 0
Malaysia
State/province [91] 0 0
Kota Kinabalu
Country [92] 0 0
Malaysia
State/province [92] 0 0
Kuala Lumpur
Country [93] 0 0
Malaysia
State/province [93] 0 0
Perak
Country [94] 0 0
Malaysia
State/province [94] 0 0
Pulau Pinang
Country [95] 0 0
Malaysia
State/province [95] 0 0
Selangor
Country [96] 0 0
Mexico
State/province [96] 0 0
Michoacán
Country [97] 0 0
Mexico
State/province [97] 0 0
Nuevo Leon
Country [98] 0 0
New Zealand
State/province [98] 0 0
Tauranga
Country [99] 0 0
Philippines
State/province [99] 0 0
Pasig city
Country [100] 0 0
Philippines
State/province [100] 0 0
Taguig City
Country [101] 0 0
Poland
State/province [101] 0 0
Gdansk
Country [102] 0 0
Poland
State/province [102] 0 0
Gdynia
Country [103] 0 0
Poland
State/province [103] 0 0
Krakow
Country [104] 0 0
Poland
State/province [104] 0 0
Lublin
Country [105] 0 0
Portugal
State/province [105] 0 0
Porto
Country [106] 0 0
Romania
State/province [106] 0 0
Brasov
Country [107] 0 0
Romania
State/province [107] 0 0
Bucuresti
Country [108] 0 0
Romania
State/province [108] 0 0
Cluj-Napoca
Country [109] 0 0
Romania
State/province [109] 0 0
Craiova
Country [110] 0 0
Romania
State/province [110] 0 0
Targu Mures
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Chelyabinsk
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Irkutsk
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Kazan
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Kemerovo
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Kirov
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Novosibirsk
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Omsk
Country [118] 0 0
Russian Federation
State/province [118] 0 0
St. Petersburg
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Volgograd
Country [120] 0 0
Singapore
State/province [120] 0 0
Singapore
Country [121] 0 0
Slovakia
State/province [121] 0 0
Poprad
Country [122] 0 0
South Africa
State/province [122] 0 0
Eastern Cape
Country [123] 0 0
South Africa
State/province [123] 0 0
Gauteng
Country [124] 0 0
Spain
State/province [124] 0 0
Madrid
Country [125] 0 0
Spain
State/province [125] 0 0
Barcelona
Country [126] 0 0
Spain
State/province [126] 0 0
Málaga
Country [127] 0 0
Spain
State/province [127] 0 0
Salamanca
Country [128] 0 0
Taiwan
State/province [128] 0 0
Changhua
Country [129] 0 0
Taiwan
State/province [129] 0 0
Kaohsiung
Country [130] 0 0
Taiwan
State/province [130] 0 0
Tainan
Country [131] 0 0
Taiwan
State/province [131] 0 0
Taipei
Country [132] 0 0
Thailand
State/province [132] 0 0
Chiangmai
Country [133] 0 0
Thailand
State/province [133] 0 0
Pathumthani
Country [134] 0 0
Turkey
State/province [134] 0 0
Ankara
Country [135] 0 0
Turkey
State/province [135] 0 0
Istanbul
Country [136] 0 0
Turkey
State/province [136] 0 0
Izmir
Country [137] 0 0
Turkey
State/province [137] 0 0
Kayseri
Country [138] 0 0
Turkey
State/province [138] 0 0
Trabzon
Country [139] 0 0
Ukraine
State/province [139] 0 0
Cherkasy
Country [140] 0 0
Ukraine
State/province [140] 0 0
Dnipro
Country [141] 0 0
Ukraine
State/province [141] 0 0
Kyiv
Country [142] 0 0
Ukraine
State/province [142] 0 0
Lviv
Country [143] 0 0
Ukraine
State/province [143] 0 0
Vinnitsa
Country [144] 0 0
Vietnam
State/province [144] 0 0
Ha Noi
Country [145] 0 0
Vietnam
State/province [145] 0 0
Ho Chi Minh City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Matasar MJ, Capra M, Ozcan M, Lv F, Li W, Yanez E,... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT02367040