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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02763319




Registration number
NCT02763319
Ethics application status
Date submitted
30/04/2016
Date registered
5/05/2016

Titles & IDs
Public title
A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Scientific title
A Phase 2/3, Randomised, Multicentre Study of Tafasitamab With Bendamustine Versus Rituximab With Bendamustine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT)
Secondary ID [1] 0 0
2014-004689-11
Secondary ID [2] 0 0
MOR208C204
Universal Trial Number (UTN)
Trial acronym
B-MIND
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 - Rituximab (RTX)
Treatment: Drugs - Tafasitamab

Experimental: Tafasitamab and bendamustine - Tafasitamab and bendamustine

Active comparator: Rituximab and bendamustine - Rituximab and bendamustine


Treatment: Drugs: Rituximab (RTX)
Rituximab: Dose: 375 mg/m2 IV

Treatment: Drugs: Tafasitamab
Tafasitamab: Tafasitamab dose: 12 mg/kg intravenously (IV)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
From date of randomization until recurrence/disease progression, unacceptable toxicity, death or discontinuation for any other reason, whichever comes first assessed up to 4 yrs
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
From date of randomization assessed up to 4 yrs
Secondary outcome [2] 0 0
Duration of response (DoR)
Timepoint [2] 0 0
From date of randomization assessed up to 4 yrs
Secondary outcome [3] 0 0
overall survival (OS)
Timepoint [3] 0 0
From date of randomization assessed up to 4 yrs
Secondary outcome [4] 0 0
disease control rate (DCR)
Timepoint [4] 0 0
From date of randomization assessed up to 4 yrs
Secondary outcome [5] 0 0
time to progression (TTP)
Timepoint [5] 0 0
From date of randomization assessed up to 4 yrs
Secondary outcome [6] 0 0
time to next treatment (TTNT)
Timepoint [6] 0 0
From date of randomization assessed up to 4 yrs
Secondary outcome [7] 0 0
Number of patients with adverse events
Timepoint [7] 0 0
assessed up to 4 yrs
Secondary outcome [8] 0 0
quality of life (QoL)
Timepoint [8] 0 0
assessed up to 4 yrs
Secondary outcome [9] 0 0
Number of patients developing Tafasitamab antibodies
Timepoint [9] 0 0
assessed up to 2 yrs
Secondary outcome [10] 0 0
Maximum Plasma Concentration of Tafasitamab (Cmax)
Timepoint [10] 0 0
assessed up to 2 yrs
Secondary outcome [11] 0 0
Apparent trough concentration (Cpd) of Tafsitamab
Timepoint [11] 0 0
assessed up to 2 yrs

Eligibility
Key inclusion criteria
INCLUSION CRITERIA:

1. Age =18 years
2. Histologically confirmed diagnosis, according to the World Health Organization (WHO, 2008) classification, of: DLBCL NOS, THRLBCL, EBV-positive DLBCL, composite lymphoma with a DLBCL component with a DLBCL relapse subsequent to DLBCL treatment, disease transformed from an earlier diagnosis of low grade lymphoma (i.e. an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with a DLBCL relapse subsequent to DLBCL treatment.
3. Fresh tumour tissue for central pathology review must be provided as an adjunct to participation in this study. Should it not be possible to obtain a fresh tumour tissue sample, archival paraffin embedded tumour tissue acquired =3 years prior to screening for this protocol must be available for this purpose.
4. Patients must have:

1. relapsed or refractory DLBCL
2. at least one bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of =1.5 cm and greatest perpendicular diameter of =1.0 cm at baseline. The lesion must be positive on PET scan
3. received at least one, but no more than three previous systemic therapy lines for the treatment of DLBCL. At least one previous therapy line must have included a CD20-targeted.
4. ECOG 0 to 2
5. Patients after failure of ASCT or patients considered in the opinion of the investigator currently not eligible for HDC with subsequent ASCT.
6. Patients must meet the following laboratory criteria at Screening:

1. ANC =1.5 × 109/L (unless secondary to bone marrow involvement by DLBCL)
2. PLTs =90 × 109/L (unless secondary to bone marrow involvement by DLBCL) and absence of active bleeding
3. total serum bilirubin =2.5 × ULN unless secondary to Gilbert's syndrome (or pattern consistent with Gilbert's) or documented liver involvement by lymphoma. Patients with Gilbert's syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is =5 x ULN
4. ALT, AST and AP =3 × ULN or <5 × ULN in cases of documented liver involvement by lymphoma
5. serum creatinine =2.0 x ULN or creatinine clearance must be =40 mL/min calculated using a standard Cockcroft-Gault formula (Cockroft & Gault, 1976)
7. For a female of childbearing potential (FCBP), a negative pregnancy test must be confirmed before enrolment. An FCBP must commit to take highly effective contraceptive precautions without interruption during the study and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or RTX respectively, whichever is later. An FCBP must refrain from breastfeeding and donating blood or oocytes during the course of the study and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or RTX respectively, whichever is later. Restrictions concerning blood donations apply as well to females who are not of childbearing potential.
8. Males must use an effective barrier method of contraception without interruption during the study and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or RTX respectively, whichever is later, if the patient is sexually active with an FCBP. Males must refrain from donating blood or sperm during study participation and for 3, 6 or 12 months after the last dose of Tafasitamab, BEN or RTX respectively, whichever is later.
9. In the opinion of the investigator, the patients must:

1. be able to comply with all study-related procedures, medication use, and evaluations
2. be able to understand and give informed consent
3. not be considered to be potentially unreliable and/or not cooperative.

EXCLUSION CRITERIA:

1. Patients who have: any other histological type of lymphoma including, e.g., primary mediastinal (thymic) large B-cell lymphoma (PMBL) or Burkitt's lymphoma, primary refractory DLBCL, patients with known "double/triple hit" DLBCL genetics, CNS lymphoma involvement in present or past medical history
2. Patients who had a major surgery less than 30 days prior to Day 1 dosing
3. Patients who have, within 14 days prior to Day 1 dosing:

1. not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
2. received live vaccines
3. required parenteral antimicrobial therapy for active, intercurrent systemic infections
4. Patients who:

1. in the opinion of the investigator, have not recovered sufficiently from the adverse toxic effects of prior therapies, major surgeries or significant traumatic injuries
2. were previously treated with CD19-targeted therapy or BEN
3. have a history of previous severe allergic reactions to compounds of similar biological or chemical composition to Tafasitamab, RTX, murine proteins or BEN, or the excipients contained in the study drug formulations
4. have undergone ASCT within a period of =3 months prior to signing the informed consent form. Patients who have a more distant history of ASCT must exhibit full haematological recovery before enrolment into the study.
5. have undergone previous allogeneic stem cell transplantation
6. concurrently use other anticancer or experimental treatments
5. Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for =3 years prior to Screening. Exceptions to the =3-year time limit include history of the following:

1. basal cell carcinoma of the skin
2. squamous cell carcinoma of the skin
3. carcinoma in situ of the cervix, breast and bladder

f) incidental histological finding of prostate cancer (Tumour/Node/Metastasis [TNM] stage of T1a or T1b)
6. Patients with:

1. positive hepatitis B and/or C serology
2. known seropositivity for or history of active viral infection with HIV
3. evidence of active, severe uncontrolled systemic infections or sepsis
4. a history or evidence of severely immunocompromised state
5. a history or evidence of severe hepatic impairment (total serum bilirubin > 3 mg/dL), jaundice unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma
6. a history or evidence of clinically significant cardiovascular, cerebrovascular, CNS and/or other disease that, in the investigator's opinion, would preclude participation in the study or compromise the patient's ability to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/06/2024
Sample size
Target
Accrual to date
Final
450
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
MorphoSys Research Site - Adelaide
Recruitment hospital [2] 0 0
MorphoSys Research Site - Albury
Recruitment hospital [3] 0 0
MorphoSys Research Site - Bedford Park
Recruitment hospital [4] 0 0
MorphoSys Research Site - Box Hill
Recruitment hospital [5] 0 0
MorphoSys Research Site - Concord
Recruitment hospital [6] 0 0
MorphoSys Research Site - Frankston
Recruitment hospital [7] 0 0
MorphoSys Research SIte - Garran
Recruitment hospital [8] 0 0
MorphoSys Research Site - Geelong
Recruitment hospital [9] 0 0
MorphoSys Research Site - Gosford
Recruitment hospital [10] 0 0
MorphoSys Research Site - Nedlands
Recruitment hospital [11] 0 0
MorphoSys Research Site - South Brisbane
Recruitment hospital [12] 0 0
MorphoSys Research Site - St. Albans
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2640 - Albury
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
2139 - Concord
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
2605 - Garran
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
2250 - Gosford
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment postcode(s) [11] 0 0
4101 - South Brisbane
Recruitment postcode(s) [12] 0 0
3021 - St. Albans
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
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Austria
State/province [12] 0 0
Innsbruck
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Manitoba
Country [15] 0 0
Canada
State/province [15] 0 0
New Brunswick
Country [16] 0 0
Canada
State/province [16] 0 0
Newfoundland and Labrador
Country [17] 0 0
Canada
State/province [17] 0 0
Ontario
Country [18] 0 0
Canada
State/province [18] 0 0
Quebec
Country [19] 0 0
Canada
State/province [19] 0 0
Saskatoon
Country [20] 0 0
Croatia
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Zagreb
Country [21] 0 0
Czechia
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Hradec Kralove
Country [22] 0 0
Czechia
State/province [22] 0 0
Olomouc
Country [23] 0 0
Czechia
State/province [23] 0 0
Prague
Country [24] 0 0
Finland
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Oulu
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Finland
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Tampere
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France
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Grenoble
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France
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Le Mans
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Düsseldorf
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Germany
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Giessen
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Germany
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Homburg
Country [33] 0 0
Germany
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Leipzig
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Germany
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Mainz
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Germany
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Munich
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Germany
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Mutlangen
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Germany
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Münster
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Germany
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Rostock
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Germany
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Stuttgart
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Germany
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Traunstein
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Gyor
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Hungary
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Szeged
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Tel Aviv
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Italy
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Alessandria
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Italy
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Bologna
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Campobasso
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Cona
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Genova
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Lecce
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Meldola
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Monza
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Napoli
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Novara
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Orbassano
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Italy
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Parma
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Italy
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Pavia
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Italy
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Pisa
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Italy
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Ravenna
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Italy
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Reggio Emilia
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Italy
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Rimini
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Italy
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Rome
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Italy
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Terni
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Italy
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Turin
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Korea, Republic of
State/province [69] 0 0
Busan
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Incheon
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Seongnam
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Korea, Republic of
State/province [74] 0 0
Seoul
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Korea, Republic of
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Ulsan
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New Zealand
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Addington
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New Zealand
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Auckland
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New Zealand
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Grafton
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Poland
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Bydgoszcz
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Gdynia
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Kraków
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Legnica
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Lodz
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Lublin
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Warszawa
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Wroclaw
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Portugal
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Braga
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Portugal
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Coimbra
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Portugal
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Matosinhos
Country [90] 0 0
Portugal
State/province [90] 0 0
Porto
Country [91] 0 0
Portugal
State/province [91] 0 0
Pragal
Country [92] 0 0
Romania
State/province [92] 0 0
Bucharest
Country [93] 0 0
Romania
State/province [93] 0 0
Iasi
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Singapore
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Singapore
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Spain
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Cadiz
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Spain
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Girona
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Spain
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L'Hospitalet De Llobregat
Country [100] 0 0
Spain
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Madrid
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Spain
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Palma de Mallorca
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Spain
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Pamplona
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Spain
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Pozuelo De Alarcón
Country [104] 0 0
Spain
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Sabadell
Country [105] 0 0
Spain
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Salamanca
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Spain
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Valencia
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Taiwan
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Chang Hua
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Taiwan
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Hualien City
Country [109] 0 0
Taiwan
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Taichung City
Country [110] 0 0
Turkey
State/province [110] 0 0
Adana
Country [111] 0 0
Turkey
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Ankara
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Turkey
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Bornova
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Turkey
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Gaziantep
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Turkey
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Izmir
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Turkey
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Manisa
Country [116] 0 0
Turkey
State/province [116] 0 0
Samsun
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Birmingham
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Leeds
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Southend on Sea

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
Incyte Medical Director
Address 0 0
Incyte Corporation
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


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/NCT02763319