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A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Copanlisib in Combination With Rituximab in Patients With Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
The purpose of this study is to assess whether copanlisib in combination with rituximab is effective and safe compared with placebo in combination with rituximab in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and alkylating agents.
Approximately 567 patients will be randomly assigned in in blinded treatment arms copanlisib plus rituximab or placebo plus rituximab.
Copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Placebo dosing will be administered on the same days as copanlisib.
Rituximab dose is administered weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day 1 of Cycles 3, 5, 7 and 9. The maximum administration of rituximab is 8 times.
Copanlisib or placebo treatment will be continued until disease progression, unacceptable toxicity, or until another criterion is met for withdrawal from the study treatment.
Following the end of treatment visit, patients will enter either the Safety follow-up or the Active follow-up period.
The efficacy is measured by duration of progression-free survival (time between randomization and onset of a further progression of disease, or death from any cause). Progression of disease will be determined by radiologic tumor assessments to be performed at screening, as well as during the active follow up period tumor assessments every 8 weeks during Year 1, every 12 weeks during Year 2, and every 24 weeks during Year 3.
Blood samples will be collected for safety analysis and pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis and for central pathology review, fresh biopsy tissue will be collected but not mandatory.