A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Official Title

A Phase 2/3, Randomised, Multicentre Study of Tafasitamab With Bendamustine Versus Rituximab With Bendamustine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT)


The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.

Trial Description

Primary Outcome:

  • Progression-free survival (PFS)
Secondary Outcome:
  • Objective response rate (ORR)
  • Duration of response (DoR)
  • overall survival (OS)
  • disease control rate (DCR)
  • time to progression (TTP)
  • time to next treatment (TTNT)
  • Number of patients with adverse events
  • quality of life (QoL)
  • Number of patients developing Tafasitamab antibodies
  • Maximum Plasma Concentration of Tafasitamab (Cmax)
  • Apparent trough concentration (Cpd) of Tafsitamab
This is a randomised, two-arm, multicentre, open-label phase II/III efficacy and safety study of Tafasitamab in combination with BEN versus RTX in combination with BEN given to adult patients who have relapsed after or are refractory to at least one but no more than three prior systemic therapies and have failed, or are not candidates for HDC and ASCT, and have thus exhausted their therapeutic options of demonstrated clinical benefit. At least one prior therapy line must have included a CD20-targeted therapy.

View this trial on ClinicalTrials.gov

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