Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

Official Title

A Phase 3, Multicentre, 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)


This is a phase 3, multicentre, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Trial Description

Primary Outcome:

Secondary Outcome:
  • OS
  • Metabolic PET-negative CR-rate at EOT by BIRC
  • Metabolic PET-negative CR-rate at EOT by INV
  • MRD status at EOT
  • PFS at 3 years
  • EFS at 3 years
  • OS at 3 years
  • ORR as per INV at EOT

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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