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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
Date last updated
15/08/2024

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
Progression Free Survival (PFS) in FL population
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) in FL and MZL populations
Timepoint [1] 0 0
Up to 6 years
Secondary outcome [2] 0 0
Complete Response in FL population
Timepoint [2] 0 0
Up to 6 years
Secondary outcome [3] 0 0
Minimal Residual Disease-negativity rate in FL and MZL Population
Timepoint [3] 0 0
14 months
Secondary outcome [4] 0 0
Overall Survival in FL Population
Timepoint [4] 0 0
Up to 6 years
Secondary outcome [5] 0 0
Complete Response in Overall population
Timepoint [5] 0 0
Up to 6 years
Secondary outcome [6] 0 0
Overall Survival in overall Population
Timepoint [6] 0 0
Up to 6 years
Secondary outcome [7] 0 0
Best Overall Response Rate in FL and overall population
Timepoint [7] 0 0
Up to 6 years
Secondary outcome [8] 0 0
Duration of Response in FL and overall population
Timepoint [8] 0 0
Up to 6 years
Secondary outcome [9] 0 0
Quality-of-Life Assessments in FL and overall populations
Timepoint [9] 0 0
Up to 6 years
Secondary outcome [10] 0 0
Safety: Number of participants with TEAE's
Timepoint [10] 0 0
13 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
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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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Bristol
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Leicester
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London
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Manchester
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Middlesbrough
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Sutton
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United Kingdom
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Wolverhampton

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04680052
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
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04680052