Last updated on November 2015

Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)


Brief description of study

The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab and alkylating agents.

Detailed Study Description

Patients should be in need of and fit for immunochemotherapy and should not be resistant to rituximab (resistance defined as lack of response, or progression within 6 months of the last course of treatment with a rituximab containing regimen). This study will be composed of two parts: Safety run-in and phase III part. The purpose of the safety run-in part of this study is to assess whether the drug being tested (copanlisib) in combination with standard immunochemotherapy (R-B or R-CHOP) is safe and at what dose level of the study drug (copanlisib - 45mg or 60 mg) patients are able to tolerate the study treatment combination. In addition to finding a safe and tolerable dose level for the phase III part of the study, efficacy will also be evaluated for patients that stay on the study treatment during the safety run-in. The phase III part of the study will start when the recommended dose of copanlisib in combination with R-CHOP and R-B has been defined and confirmed by sponsor, principal investigator and Data Monitoring Committee. A maximum of 24 patients will take part in the safety run-in part of this study. In the phase III part approximately 676 patients will be randomly assigned to blinded treatment arms of copanlisib plus R-B or R-CHOP or placebo plus R-B or R-CHOP.

Clinical Study Identifier: NCT02626455

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