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About this trial

The purpose of this study is to evaluate the efficacy and safety of 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]) compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP).

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 (disease becomes worse) 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. Ireland will participate in the phase III part of this study.

In the phase III part approximately 520 patients will be randomly assigned to blinded (patients and doctors do not know which treatment is being given) treatment arms of copanlisib plus R-B or R-CHOP or placebo plus R-B or R-CHOP.

Patient Profile

Indolent (grow slowly) Non-Hodgkin’s Lymphoma that have returned after previous treatment.

Where’s this trial being run?

Cork University Hospital 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.

For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: CHRONOS-4
Number: 17-06
Full Title:

A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin’s Lymphoma (iNHL).

Principal Investigator: Dr Anne Fortune (Mater Misericordiae University Hospital)
Type: Industry Sponsored
Sponsor:

Bayer

Recruitment Started: Global: January 2016
Ireland: July 2017
Global Recruitment Target:
Ireland Recruitment Target: