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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
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
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05000 - Adelaide
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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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Kaohsiung
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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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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

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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.incyte.com/our-company/compliance-and-transparency


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