Phase 3 double-blind trial of tafasitamab plus lenalidomide in DLBCL

• Research type

  Research Study

• Full title

  A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B-cell lymphoma (DLBCL)

• IRAS ID

  1003516

• Contact name

  Silvia Stingele

• Sponsor organisation

  MorphoSys AG

• Eudract number

  2020-002990-84

• Research summary

  This is phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP (chemotherapy medicines and the monoclonal antibody rituximab) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B-cell lymphoma (DLBCL).
  Tafasitamab is a monoclonal antibody that targets lymphoma cells and helps the immune system to destroy these cancer cells. Lenalidomide is an anticancer drug that affects the immune system and promotes immune responses to help slow tumour growth.
  The participants will have a 50% (1 in 2) chance of being in the experimental group or the control group. Neither they nor the study doctor will know which treatment they are assigned to. In addition to R-CHOP participants will receive:
  • Tafasitamab in combination with lenalidomide (experimental group)
  • Tafasitamab placebo in combination with lenalidomide placebo (control group)

  Tafasitamab or tafasitamab placebo will be administered directly into a vein as a weekly infusion which lasts approximately 2 hours. Lenalidomide or lenalidomide placebo capsule will be taken whole and swallowed with water once a day for 10 consecutive days every 3 weeks.
  If the participants agree to join this study, their study participation may last for up to 5 years.
  The study will consist of:
  • Screening Period (to be completed within 21 days),
  • Treatment Period (18 weeks; 6 cycles of 21 days)
  • End of Treatment visit or Early Study Treatment Discontinuation visit
  • Follow-up period of up to 60 months (visits every three months for the first two years, and every six months for the remainder)
  • Extended follow-up every 6 months via telephone contact until the close of the study.
  This is a global study and it is being funded by MorphoSys AG.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0134

• Date of REC Opinion

  24 Mar 2021

• REC opinion

  Further Information Favourable Opinion