Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Official Title

An Open-label, Single-arm Phase II Study in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) to Evaluate Efficacy and Safety of Treatment With Single Agent Copanlisib and the Impact of Biomarkers Thereupon.


To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker

Trial Description

Primary Outcome:

  • Objective Response
  • Objective response in CD79B mutant patient population
  • Objective response in CD79B wild-type patient population
  • Objective response in cell-of-origin ABC patient population
  • Objective response in cell-of-origin GCB patient population
  • Objective response in unclassifiable cell-of-origin patient population
Secondary Outcome:
  • Duration of response (DOR)
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Disease control rate (DCR)
  • Duration of stable disease (DOSD)
  • Number of participants with adverse events as a measure of safety and tolerability

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society