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

• 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