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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.
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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
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Secondary ID [1]
0
0
INCMOR 0208-301
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Universal Trial Number (UTN)
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Trial acronym
InMIND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma
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Marginal Zone Lymphoma
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Condition category
Condition code
Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) in FL population
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Assessment method [1]
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Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.
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Timepoint [1]
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Up to 6 years
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Secondary outcome [1]
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Progression Free Survival (PFS) in FL and MZL populations
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Assessment method [1]
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Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.
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Timepoint [1]
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Up to 6 years
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Secondary outcome [2]
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Complete Response in FL population
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Assessment method [2]
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Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit
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Timepoint [2]
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Up to 6 years
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Secondary outcome [3]
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Minimal Residual Disease-negativity rate in FL and MZL Population
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Assessment method [3]
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Defined as less than 1 residual tumor cell per 10\^4 normal cells in peripheral blood and bone marrow.
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Timepoint [3]
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14 months
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Secondary outcome [4]
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Overall Survival in FL Population
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Assessment method [4]
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Defined as survival from time of study randomization to death of any cause.
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Timepoint [4]
0
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Up to 6 years
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Secondary outcome [5]
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Complete Response in Overall population
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Assessment method [5]
0
0
Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit
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Timepoint [5]
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Up to 6 years
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Secondary outcome [6]
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Overall Survival in overall Population
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Assessment method [6]
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Defined as survival from time of study initiation to death of any cause.
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Timepoint [6]
0
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Up to 6 years
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Secondary outcome [7]
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Best Overall Response Rate in FL and overall population
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Assessment method [7]
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Defined as proportion of participants whose best overall response was a complete response (CR) or partial response (PR).
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Timepoint [7]
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Up to 6 years
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Secondary outcome [8]
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Duration of Response in FL and overall population
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Assessment method [8]
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Defined as the time to the first response to evidence of progression.
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Timepoint [8]
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Up to 6 years
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Secondary outcome [9]
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Quality-of-Life Assessments in FL and overall populations
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Assessment method [9]
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Defined as a patient self evaluation questionnaire
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Timepoint [9]
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Up to 6 years
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Secondary outcome [10]
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Safety: Number of participants with TEAE's
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Assessment method [10]
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Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment.
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Timepoint [10]
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13 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
9/08/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
654
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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St George Hospital - Kogarah
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Liverpool Hospital - Sydney
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Wollongong Hospital - Illawarra Regional Hospital - Wollongong
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Gold Coast Hospital - Southport
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Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre - Bedford Park
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The Alfred Hospital - Melbourne
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Northern Hospital - Melbourne
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Western Health - St. Albans
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Perth Blood Institute - West Perth
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Recruitment hospital [11]
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Eastern Health - Box Hill
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Recruitment hospital [12]
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Royal Hobart Hospital - Hobart
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Recruitment postcode(s) [1]
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02217 - Kogarah
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Recruitment postcode(s) [2]
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02170 - Sydney
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02500 - Wollongong
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Recruitment postcode(s) [4]
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04215 - Southport
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Recruitment postcode(s) [5]
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05000 - Adelaide
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Recruitment postcode(s) [6]
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05042 - Bedford Park
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Recruitment postcode(s) [7]
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03004 - Melbourne
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Recruitment postcode(s) [8]
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03076 - Melbourne
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03021 - St. Albans
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06005 - West Perth
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Recruitment postcode(s) [11]
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3128 - Box Hill
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Recruitment postcode(s) [12]
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07000 - Hobart
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Recruitment outside Australia
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California
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Italy
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Rimini
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Italy
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Roma
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Italy
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Rome
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Italy
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San Martino
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Italy
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Torino
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Italy
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Trieste
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Japan
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Fukuyama-shi
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Japan
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Gifu-shi
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Japan
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Kagoshima-shi
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Japan
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Kashiwa-shi
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Japan
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Narita City
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Osakasayama-shi
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Japan
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Saitama
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Japan
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Tokyo
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Tsu-shi
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Japan
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Yamagata-shi
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Korea, Republic of
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Busan-si
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Busan
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Daegu
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Daejeon
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Incheon
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Jeonju
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Seoul
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Netherlands
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Amsterdam
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Arnhem
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Netherlands
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Enschede
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Netherlands
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Leidschendam
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Norway
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Brumunddal
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Trondheim
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Poland
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Brzozow
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Poland
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Katowice
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Krakow
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Lodz
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Lublin
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Poland
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Tomaszow Mazowiecki
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Poland
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Warszawa
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Poland
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Russian Federation
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Rostov-on-don
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Russian Federation
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St.petersburg
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A Coruña
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Alicante
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Badalona
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Spain
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Barcelona
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Burgos
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Spain
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Gijon
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Spain
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Hospitalet de Llobregat
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Spain
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Madrid
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Spain
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Majadahonda
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Malaga
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Murcia
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Palma de Mallorca
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Sabadell
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Salamanca
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Santander
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Sevilla
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Terrassa
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Valencia
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Vitoria-gasteiz
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Sweden
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Solna
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Sweden
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Uddevalla
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Sweden
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Uppsala
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Basel
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Switzerland
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Bellinzona
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Switzerland
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Bern
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Switzerland
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St. Gallen
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Switzerland
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Winterthur
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Switzerland
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Zurich
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Taiwan
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Kaohsiung City
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Kaohsiung
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Taiwan
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Taichung
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Tainan
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Taipei City
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Taipei
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Turkey
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Ankara
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Turkey
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Istanbul
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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United Kingdom
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Birmingham
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United Kingdom
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Bristol
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesbrough
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United Kingdom
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Sutton
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Incyte Corporation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.
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Trial website
https://clinicaltrials.gov/study/NCT04680052
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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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
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What data in particular will be shared?
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
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Available to whom?
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency
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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/NCT04680052