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

• Status: Completed
• Trial end date: 2018-01-19
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

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.