Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Exclusion Criteria

• •A fresh tumor biopsy collected during screening and /or archival tumor tissue collected after the last relapse/disease progression.
• •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
• •Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN) for the Institution. (as per local standard of care) as measured by echocardiogram (ECHO) or Multiple gated acquisition (MUGA) scan.
• •Adequate bone marrow, liver and renal function.
• •Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only.
• •Active CTCAE (Common Terminology Criteria for Adverse Events) Grade 3/4 infection.
• •Current central nervous system (CNS) involvement by lymphoma.
• •Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction within the past 6 months before start of study treatment.
• •Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
• •Type I or II diabetes mellitus with HbA1c \> 8.5% at Screening.
• •New York Heart Association (NYHA) class III or IV heart disease.
• •History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).