About this trial
The purpose of this study is to find out if the drug copanlisib in combination with rituximab is superior to placebo in combination with rituximab in patients with whose iNHL has returned and who have received one or more lines of treatment, including 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.
Patients with indolent B-cell non-Hodgkin’s lymphoma that has returned.
Blood samples will be collected for safety analysis and pharmacokinetic analysis. Archival tumour tissue and blood samples will be collected for biomarker analysis and for central pathology review, fresh biopsy tissue and bone marrow will be collected but not mandatory.
Where’s this trial being run?St James’s Hospital, St Vincents University Hospital, University Hospital Galway, and Mater Misericordiae University Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
Why not Print this page and bring it with you. It will help your doctor and research team advise you.Print this page
For more detailed informationClick Here
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)
|Principal Investigator:||Prof Elisabeth Vandenberghe (St James's Hospital)|
Global: June 2015
Ireland: October 2015
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|Ireland Recruitment Target:|