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 Rate (ORR) in Total Population Based on Investigator Assessment
  • 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 Patients With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

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