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Closed (no longer recruiting)Last updated: 7 February 2024

InMIND: This Phase III trial is evaluating the effectiveness of targeted therapy (tafasitamab), compared with a placebo, is when combined with other cancer drugs (lenalidomide and rituximab) in people with relapsed or refractory follicular lymphoma or marginal zone lymphomaA 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

Clinical summary

Summary

This is a randomised, double blind trial with an experimental and a placebo comparator arm. Participants in the Experimental arm will receive tafasitamab + rituximab + lenalidomide. Tafasitamab will be administered intravenously (IV) for 12 cycles. Rituximab will be administered via IV on cycles 1-5. Lenalidomide will be administered orally for 12 cycles. Participants in the Placebo Comparator arm will receive placebo + rituximab + lenalidomide. The Placebo will be administered via IV for 12 cycles. Rituximab will be administered via IV on cycles 1-5. Lenalidomide will be administered orally for 12 cycles.

Conditions

This trial is treating patients with follicular lymphoma and marginal zone lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

InMIND

More information

Trial Identifiers

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Trial sponsor

Incyte Corporation

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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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