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

• 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