Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
Condition: Diffuse, Large B-Cell, Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Intervention: Copanlisib (Aliqopa, BAY80-6946)
Intervention description: Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  Not eligible or not willing to receive the high-dose (myeloablative) chemotherapy
             (HDC) and stem cell transplant (SCT).

          -  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.

        Exclusion Criteria:

          -  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).

          -  Patients who previously received therapy with copanlisib or other PI3K inhibitors are
             not eligible for enrollment.