Evaluate the Efficacy and Safety of Tafasitamab plus Lenalidomide

• Research type

  Research Study

• Full 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.

• IRAS ID

  295726

• Contact name

  Shankaranarayana Paneesha

• Contact email

  shankara.paneesha@nhs.net

• Sponsor organisation

  Incyte Corporation

• Eudract number

  2020-004407-13

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  Tafasitamab (MOR00208) is an investigational drug that is being studied by Incyte Corporation (“Sponsor”) for use in the treatment of patients with relapsed/refractory (R/R) follicular lymphoma (FL) Grade 1 to 3a or with R/R marginal zone lymphoma (MZL).
  Tafasitamab is a molecule that works by attaching to the CD19 protein found on the surface of blood cells – cancer cells, and some healthy blood cells. After attaching to the CD19 protein, Tafasitamab is thought to work by helping the immune system destroy the cancer cells.

  Cancer patients who have FcγR allotypes that bind with higher affinity to the constant region of therapeutic antibodies have been reported to respond better to immunotherapy.

  The purpose of this Study is to compare the safety and therapeutic effects of the Study Drug + rituximab and lenalidomide compared to placebo + rituximab and lenalidomide in participants with FL or MZL that came back (relapsed) or did not respond to treatment (refractory).

  The study duration for an individual participant is divided into the screening period (up to 28 days), treatment period (twelve 28-day cycles), EOT (4-8 weeks after last treatment), and follow-up period (up to 60 months after EOT).
  The total duration is up to approximately 6 years per participant.

  Approximately 275 centres globally (Europe, Asia Pacific [APAC], North America) will be participating in this study.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  21/SC/0151

• Date of REC Opinion

  9 Jul 2021

• REC opinion

  Further Information Favourable Opinion