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 Rate (ORR) in Total Population Based on Investigator Assessment
  • ORR by CD79b Status Based on Investigator Assessment
  • ORR by DLBCL/COO Subtype Based on Investigator Assessment
Secondary Outcome:
  • Duration of Response (DOR) in Total Population
  • DOR by CD79b Status
  • DOR by DLBCL/COO Subtype
  • Progression-free Survival (PFS) in Total Population
  • PFS by CD79b Status
  • PFS by DLBCL/COO Subtype
  • Overall Survival (OS) in Total Population
  • OS by CD79b Status
  • OS by DLBCL/COO Subtype
  • Duration of Stable Disease (DOSD) in Total Population
  • Disease Control Rate (DCR) in Total Population
  • DCR by CD79b Status
  • DCR by DLBCL/COO Subtype
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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Canadian Cancer Society

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