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 (InMIND)

  • STATUS
    Recruiting
  • End date
    Aug 9, 2028
  • participants needed
    618
  • sponsor
    Incyte Corporation
Updated on 21 September 2022
rituximab
lenalidomide
follicular lymphoma
marginal zone lymphoma

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.

Details
Condition Follicular Lymphoma, Marginal Zone Lymphoma
Treatment Rituximab, Placebo, Lenalidomide, Tafasitamab
Clinical Study IdentifierNCT04680052
SponsorIncyte Corporation
Last Modified on21 September 2022

Eligibility

Yes No Not Sure

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

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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