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.

Summary:

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

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society