Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or DLBCL transformed from follicular lymphoma on the basis of a tissue biopsy).
Received at least one prior therapy for aggressive Non-Hodgkin's Lymphoma (NHL) (DLBCL).
Received CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) + rituximab or equivalent regimen.
Patients must have measurable disease.
You may not be if
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).
Clareo Health | Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
