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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04680052




Registration number
NCT04680052
Ethics application status
Date submitted
17/12/2020
Date registered
22/12/2020

Titles & IDs
Public title
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Secondary ID [1] 0 0
INCMOR 0208-301
Universal Trial Number (UTN)
Trial acronym
InMIND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 0 0
Marginal Zone 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 - tafasitamab
Treatment: Drugs - rituximab
Treatment: Drugs - lenalidomide
Treatment: Drugs - placebo

Experimental: Arm A : tafasitamab + rituximab + lenalidomide - Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)

Placebo comparator: Arm B : placebo+rituximab+lenalidomide - Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)


Treatment: Drugs: tafasitamab
tafasitamab will be administered IV for 12 cycles

Treatment: Drugs: rituximab
Rituximab will be administered IV on cycles 1 - 5

Treatment: Drugs: lenalidomide
Lenalidomide will be administered PO for 12 cycles

Treatment: Drugs: placebo
placebo will be administered IV for 12 cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First
Timepoint [1] 0 0
up to approximately 34 months
Primary outcome [2] 0 0
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
Timepoint [2] 0 0
up to 2 years
Secondary outcome [1] 0 0
Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
Timepoint [1] 0 0
up to approximately 34 months
Secondary outcome [2] 0 0
Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
Timepoint [2] 0 0
up to 2 years
Secondary outcome [3] 0 0
FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria
Timepoint [3] 0 0
up to approximately 34 months
Secondary outcome [4] 0 0
FL Population: Overall Survival
Timepoint [4] 0 0
up to approximately 34 months
Secondary outcome [5] 0 0
FL Population: Kaplan-Meier Estimates of Overall Survival
Timepoint [5] 0 0
up to 2 years
Secondary outcome [6] 0 0
FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria
Timepoint [6] 0 0
up to approximately 34 months
Secondary outcome [7] 0 0
FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment
Timepoint [7] 0 0
up to approximately 34 months
Secondary outcome [8] 0 0
Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment
Timepoint [8] 0 0
up to approximately 34 months
Secondary outcome [9] 0 0
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
Timepoint [9] 0 0
up to approximately 34 months
Secondary outcome [10] 0 0
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
Timepoint [10] 0 0
up to approximately 34 months
Secondary outcome [11] 0 0
FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
Timepoint [11] 0 0
up to approximately 34 months
Secondary outcome [12] 0 0
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
Timepoint [12] 0 0
up to 2 years
Secondary outcome [13] 0 0
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
Timepoint [13] 0 0
up to approximately 34 months
Secondary outcome [14] 0 0
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
Timepoint [14] 0 0
up to 2 years
Secondary outcome [15] 0 0
Overall Population: Overall Survival
Timepoint [15] 0 0
up to approximately 34 months
Secondary outcome [16] 0 0
Overall Population: Kaplan-Meier Estimates of Overall Survival
Timepoint [16] 0 0
up to 2 years
Secondary outcome [17] 0 0
FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
Timepoint [17] 0 0
up to approximately 34 months
Secondary outcome [18] 0 0
FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
Timepoint [18] 0 0
up to 2 years
Secondary outcome [19] 0 0
Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
Timepoint [19] 0 0
up to approximately 34 months
Secondary outcome [20] 0 0
Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
Timepoint [20] 0 0
up to 2 years
Secondary outcome [21] 0 0
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
Timepoint [21] 0 0
up to approximately 34 months
Secondary outcome [22] 0 0
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
Timepoint [22] 0 0
up to approximately 34 months
Secondary outcome [23] 0 0
FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
Timepoint [23] 0 0
up to approximately 34 months
Secondary outcome [24] 0 0
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
Timepoint [24] 0 0
up to 2 years
Secondary outcome [25] 0 0
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
Timepoint [25] 0 0
up to approximately 34 months
Secondary outcome [26] 0 0
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
Timepoint [26] 0 0
up to 2 years
Secondary outcome [27] 0 0
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Timepoint [27] 0 0
up to approximately 34 months
Secondary outcome [28] 0 0
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
Timepoint [28] 0 0
up to approximately 34 months
Secondary outcome [29] 0 0
FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
Timepoint [29] 0 0
up to approximately 34 months
Secondary outcome [30] 0 0
Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
Timepoint [30] 0 0
up to approximately 34 months
Secondary outcome [31] 0 0
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Timepoint [31] 0 0
up to approximately 34 months
Secondary outcome [32] 0 0
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
Timepoint [32] 0 0
up to approximately 34 months
Secondary outcome [33] 0 0
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
Timepoint [33] 0 0
up to approximately 34 months
Secondary outcome [34] 0 0
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
Timepoint [34] 0 0
up to approximately 34 months

Eligibility
Key inclusion criteria
* Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
* Willingness to avoid pregnancy or fathering children
* In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
* Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
* Documented relapsed, refractory, or PD after treatment with systemic therapy
* ECOG performance status of 0 to 2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant or breastfeeding.
* Any histology other than FL and MZL or clinical evidence of transformed lymphoma
* Prior non-hematologic malignancy
* Congestive heart failure
* HCV positivity, chronic HBV infection or history of HIV infection
* Active systemic infection
* CNS lymphoma involvement
* Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
* Prior use of lenalidomide in combination with rituximab

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 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
15/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/08/2028
Actual
Sample size
Target
Accrual to date
Final
654
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [3] 0 0
Wollongong Hospital - Illawarra Regional Hospital - Wollongong
Recruitment hospital [4] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
Northern Hospital - Melbourne
Recruitment hospital [9] 0 0
Western Health - St. Albans
Recruitment hospital [10] 0 0
Perth Blood Institute - West Perth
Recruitment hospital [11] 0 0
Eastern Health - Box Hill
Recruitment hospital [12] 0 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 0 0
02217 - Kogarah
Recruitment postcode(s) [2] 0 0
02170 - Sydney
Recruitment postcode(s) [3] 0 0
02500 - Wollongong
Recruitment postcode(s) [4] 0 0
04215 - Southport
Recruitment postcode(s) [5] 0 0
05000 - Adelaide
Recruitment postcode(s) [6] 0 0
05042 - Bedford Park
Recruitment postcode(s) [7] 0 0
03004 - Melbourne
Recruitment postcode(s) [8] 0 0
03076 - Melbourne
Recruitment postcode(s) [9] 0 0
03021 - St. Albans
Recruitment postcode(s) [10] 0 0
06005 - West Perth
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
07000 - Hobart
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
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
South Dakota
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Austria
State/province [22] 0 0
Graz
Country [23] 0 0
Austria
State/province [23] 0 0
Innsbruck
Country [24] 0 0
Austria
State/province [24] 0 0
Linz
Country [25] 0 0
Austria
State/province [25] 0 0
Wien
Country [26] 0 0
Belgium
State/province [26] 0 0
Antwerpen
Country [27] 0 0
Belgium
State/province [27] 0 0
Brugge
Country [28] 0 0
Belgium
State/province [28] 0 0
Brussels
Country [29] 0 0
Belgium
State/province [29] 0 0
Edegem
Country [30] 0 0
Belgium
State/province [30] 0 0
Gent
Country [31] 0 0
Belgium
State/province [31] 0 0
Leuven
Country [32] 0 0
Belgium
State/province [32] 0 0
Liège
Country [33] 0 0
Belgium
State/province [33] 0 0
Roeselare
Country [34] 0 0
Belgium
State/province [34] 0 0
Yvoir
Country [35] 0 0
Canada
State/province [35] 0 0
Alberta
Country [36] 0 0
Canada
State/province [36] 0 0
British Columbia
Country [37] 0 0
Canada
State/province [37] 0 0
Nova Scotia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
Czechia
State/province [40] 0 0
Brno
Country [41] 0 0
Czechia
State/province [41] 0 0
Hradec Kralove
Country [42] 0 0
Czechia
State/province [42] 0 0
Ostrava
Country [43] 0 0
Czechia
State/province [43] 0 0
Prague
Country [44] 0 0
Czechia
State/province [44] 0 0
Praha
Country [45] 0 0
Denmark
State/province [45] 0 0
Aalborg
Country [46] 0 0
Denmark
State/province [46] 0 0
Aarhus
Country [47] 0 0
Denmark
State/province [47] 0 0
Odense
Country [48] 0 0
Denmark
State/province [48] 0 0
Roskilde
Country [49] 0 0
Finland
State/province [49] 0 0
Kuopio
Country [50] 0 0
Finland
State/province [50] 0 0
Oulu
Country [51] 0 0
Finland
State/province [51] 0 0
Tampere
Country [52] 0 0
Finland
State/province [52] 0 0
Turku
Country [53] 0 0
France
State/province [53] 0 0
Amiens
Country [54] 0 0
France
State/province [54] 0 0
Angers
Country [55] 0 0
France
State/province [55] 0 0
Bordeaux
Country [56] 0 0
France
State/province [56] 0 0
Dijon
Country [57] 0 0
France
State/province [57] 0 0
Le Chesnay
Country [58] 0 0
France
State/province [58] 0 0
Nantes
Country [59] 0 0
France
State/province [59] 0 0
Paris
Country [60] 0 0
France
State/province [60] 0 0
Pontoise
Country [61] 0 0
France
State/province [61] 0 0
Pringy
Country [62] 0 0
France
State/province [62] 0 0
Tours
Country [63] 0 0
Germany
State/province [63] 0 0
Amberg
Country [64] 0 0
Germany
State/province [64] 0 0
Berlin
Country [65] 0 0
Germany
State/province [65] 0 0
Essen
Country [66] 0 0
Germany
State/province [66] 0 0
GIEßEN
Country [67] 0 0
Germany
State/province [67] 0 0
Greifswald
Country [68] 0 0
Germany
State/province [68] 0 0
Landshut
Country [69] 0 0
Germany
State/province [69] 0 0
Mainz
Country [70] 0 0
Germany
State/province [70] 0 0
Mannheim
Country [71] 0 0
Germany
State/province [71] 0 0
Muenster
Country [72] 0 0
Germany
State/province [72] 0 0
Oldenburg
Country [73] 0 0
Germany
State/province [73] 0 0
ULM
Country [74] 0 0
Germany
State/province [74] 0 0
Würzburg
Country [75] 0 0
Greece
State/province [75] 0 0
Athens
Country [76] 0 0
Greece
State/province [76] 0 0
Patras
Country [77] 0 0
Hungary
State/province [77] 0 0
Budapest
Country [78] 0 0
Hungary
State/province [78] 0 0
Debrecen
Country [79] 0 0
Hungary
State/province [79] 0 0
Eger
Country [80] 0 0
Hungary
State/province [80] 0 0
Gyor
Country [81] 0 0
Hungary
State/province [81] 0 0
Nyíregyháza
Country [82] 0 0
Hungary
State/province [82] 0 0
Szeged
Country [83] 0 0
Ireland
State/province [83] 0 0
Dublin
Country [84] 0 0
Ireland
State/province [84] 0 0
Galway
Country [85] 0 0
Israel
State/province [85] 0 0
Afula
Country [86] 0 0
Israel
State/province [86] 0 0
Bear Sheva
Country [87] 0 0
Israel
State/province [87] 0 0
Beer Yaaqov
Country [88] 0 0
Israel
State/province [88] 0 0
Holon
Country [89] 0 0
Israel
State/province [89] 0 0
Jerusalem
Country [90] 0 0
Israel
State/province [90] 0 0
Kfar Saba
Country [91] 0 0
Israel
State/province [91] 0 0
Petah Tikva
Country [92] 0 0
Israel
State/province [92] 0 0
Tel Hashomer
Country [93] 0 0
Italy
State/province [93] 0 0
Bari
Country [94] 0 0
Italy
State/province [94] 0 0
Brescia
Country [95] 0 0
Italy
State/province [95] 0 0
Candiolo
Country [96] 0 0
Italy
State/province [96] 0 0
Catania
Country [97] 0 0
Italy
State/province [97] 0 0
Lecce
Country [98] 0 0
Italy
State/province [98] 0 0
Milano
Country [99] 0 0
Italy
State/province [99] 0 0
Naples
Country [100] 0 0
Italy
State/province [100] 0 0
Napoli
Country [101] 0 0
Italy
State/province [101] 0 0
Novara
Country [102] 0 0
Italy
State/province [102] 0 0
Orbassano
Country [103] 0 0
Italy
State/province [103] 0 0
Palermo
Country [104] 0 0
Italy
State/province [104] 0 0
Pavia
Country [105] 0 0
Italy
State/province [105] 0 0
Piacenza
Country [106] 0 0
Italy
State/province [106] 0 0
Pisa
Country [107] 0 0
Italy
State/province [107] 0 0
Ravenna
Country [108] 0 0
Italy
State/province [108] 0 0
Reggio Emilia
Country [109] 0 0
Italy
State/province [109] 0 0
Rimini
Country [110] 0 0
Italy
State/province [110] 0 0
Roma
Country [111] 0 0
Italy
State/province [111] 0 0
Rome
Country [112] 0 0
Italy
State/province [112] 0 0
San Martino
Country [113] 0 0
Italy
State/province [113] 0 0
Torino
Country [114] 0 0
Italy
State/province [114] 0 0
Trieste
Country [115] 0 0
Japan
State/province [115] 0 0
Fukuoka-shi
Country [116] 0 0
Japan
State/province [116] 0 0
Fukuyama-shi
Country [117] 0 0
Japan
State/province [117] 0 0
Gifu-shi
Country [118] 0 0
Japan
State/province [118] 0 0
Kagoshima-shi
Country [119] 0 0
Japan
State/province [119] 0 0
Kashiwa-shi
Country [120] 0 0
Japan
State/province [120] 0 0
Kitakyushu-shi
Country [121] 0 0
Japan
State/province [121] 0 0
Kobe-shi
Country [122] 0 0
Japan
State/province [122] 0 0
Nagoya-shi
Country [123] 0 0
Japan
State/province [123] 0 0
Narita City
Country [124] 0 0
Japan
State/province [124] 0 0
Osakasayama-shi
Country [125] 0 0
Japan
State/province [125] 0 0
Saitama
Country [126] 0 0
Japan
State/province [126] 0 0
Suita-shi
Country [127] 0 0
Japan
State/province [127] 0 0
Tokyo
Country [128] 0 0
Japan
State/province [128] 0 0
Tsu-shi
Country [129] 0 0
Japan
State/province [129] 0 0
Yamagata-shi
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Busan-si
Country [131] 0 0
Korea, Republic of
State/province [131] 0 0
Busan
Country [132] 0 0
Korea, Republic of
State/province [132] 0 0
Daegu
Country [133] 0 0
Korea, Republic of
State/province [133] 0 0
Daejeon
Country [134] 0 0
Korea, Republic of
State/province [134] 0 0
Incheon
Country [135] 0 0
Korea, Republic of
State/province [135] 0 0
Jeonju
Country [136] 0 0
Korea, Republic of
State/province [136] 0 0
Seoul
Country [137] 0 0
Netherlands
State/province [137] 0 0
Amsterdam
Country [138] 0 0
Netherlands
State/province [138] 0 0
Arnhem
Country [139] 0 0
Netherlands
State/province [139] 0 0
Enschede
Country [140] 0 0
Netherlands
State/province [140] 0 0
Leeuwarden
Country [141] 0 0
Netherlands
State/province [141] 0 0
Leidschendam
Country [142] 0 0
Norway
State/province [142] 0 0
Brumunddal
Country [143] 0 0
Norway
State/province [143] 0 0
Trondheim
Country [144] 0 0
Poland
State/province [144] 0 0
Brzozow
Country [145] 0 0
Poland
State/province [145] 0 0
Katowice
Country [146] 0 0
Poland
State/province [146] 0 0
Krakow
Country [147] 0 0
Poland
State/province [147] 0 0
Lodz
Country [148] 0 0
Poland
State/province [148] 0 0
Lublin
Country [149] 0 0
Poland
State/province [149] 0 0
Tomaszow Mazowiecki
Country [150] 0 0
Poland
State/province [150] 0 0
Warszawa
Country [151] 0 0
Poland
State/province [151] 0 0
Wroclaw
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Rostov-on-don
Country [153] 0 0
Russian Federation
State/province [153] 0 0
St.petersburg
Country [154] 0 0
Spain
State/province [154] 0 0
A Coruña
Country [155] 0 0
Spain
State/province [155] 0 0
Alicante
Country [156] 0 0
Spain
State/province [156] 0 0
Badalona
Country [157] 0 0
Spain
State/province [157] 0 0
Barcelona
Country [158] 0 0
Spain
State/province [158] 0 0
Burgos
Country [159] 0 0
Spain
State/province [159] 0 0
Gijon
Country [160] 0 0
Spain
State/province [160] 0 0
Hospitalet de Llobregat
Country [161] 0 0
Spain
State/province [161] 0 0
Madrid
Country [162] 0 0
Spain
State/province [162] 0 0
Majadahonda
Country [163] 0 0
Spain
State/province [163] 0 0
Malaga
Country [164] 0 0
Spain
State/province [164] 0 0
Murcia
Country [165] 0 0
Spain
State/province [165] 0 0
Palma de Mallorca
Country [166] 0 0
Spain
State/province [166] 0 0
Sabadell
Country [167] 0 0
Spain
State/province [167] 0 0
Salamanca
Country [168] 0 0
Spain
State/province [168] 0 0
Santander
Country [169] 0 0
Spain
State/province [169] 0 0
Sevilla
Country [170] 0 0
Spain
State/province [170] 0 0
Terrassa
Country [171] 0 0
Spain
State/province [171] 0 0
Valencia
Country [172] 0 0
Spain
State/province [172] 0 0
Vitoria-gasteiz
Country [173] 0 0
Sweden
State/province [173] 0 0
Solna
Country [174] 0 0
Sweden
State/province [174] 0 0
Uddevalla
Country [175] 0 0
Sweden
State/province [175] 0 0
Uppsala
Country [176] 0 0
Switzerland
State/province [176] 0 0
Basel
Country [177] 0 0
Switzerland
State/province [177] 0 0
Bellinzona
Country [178] 0 0
Switzerland
State/province [178] 0 0
Bern
Country [179] 0 0
Switzerland
State/province [179] 0 0
St. Gallen
Country [180] 0 0
Switzerland
State/province [180] 0 0
Winterthur
Country [181] 0 0
Switzerland
State/province [181] 0 0
Zurich
Country [182] 0 0
Taiwan
State/province [182] 0 0
Kaohsiung City
Country [183] 0 0
Taiwan
State/province [183] 0 0
Kaohsiung
Country [184] 0 0
Taiwan
State/province [184] 0 0
New Taipei City
Country [185] 0 0
Taiwan
State/province [185] 0 0
Taichung
Country [186] 0 0
Taiwan
State/province [186] 0 0
Tainan
Country [187] 0 0
Taiwan
State/province [187] 0 0
Taipei City
Country [188] 0 0
Taiwan
State/province [188] 0 0
Taipei
Country [189] 0 0
Turkey
State/province [189] 0 0
Ankara
Country [190] 0 0
Turkey
State/province [190] 0 0
Istanbul
Country [191] 0 0
Ukraine
State/province [191] 0 0
Kharkiv
Country [192] 0 0
Ukraine
State/province [192] 0 0
Kyiv
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Birmingham
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Bristol
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Leicester
Country [196] 0 0
United Kingdom
State/province [196] 0 0
London
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Manchester
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Middlesbrough
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Sutton
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
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


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/NCT04680052