A study investigating copanlisib in combination with standard treatment versus standard treatment alone in order to see if copanlisib improves the response to standard treatment in patients with relapsed indolent non-Hodgkin's lymphoma

Woman and Man

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Extract

Safety run-in part Primary objective is to determine: The recommended phase III dose (RP3D) of copanlisib in combination with standard immunochemotherapy (rituximab and bendamustine [RB] or rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone [R-CHOP]) to be used in the subsequent phase III part of the study Phase III part (randomized, controlled trial) Primary objective is: To evaluate whether copanlisib in combination with standard immunochemotherapy, is superior to standard immunochemotherapy in prolonging progression-free survival (PFS), in patients with relapsed indolent non-Hodgkin’s lymphoma, who have received at least one, but at most three lines of treatment, including rituximab and alkylating agents, and for whom the combination of rituximab with either bendamustine or CHOP represents a valid therapeutic option

Inclusion criteria

Patients with relapsed indolent non-Hodgkin's lymphoma

Kusajili – Clinical trials directory

A study investigating copanlisib in combination with standard treatment versus standard treatment alone in order to see if copanlisib improves the response to standard treatment in patients with relap...