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About this trial

The purpose of the study is to compare the four treatment arms described below and assess if the treatment arms that do not contain chemotherapy (treatments B, C and D below) are more effective and have fewer side effects than the standard treatment that contains chemotherapy (treatment A below):
A. Chemoimmunotherapy with either Fludarabine plus Cyclophosphamide plus Rituximab (FCR) or Bendamustine plus Rituximab (BR)
B. Rituximab plus Venetoclax (RVe)
C. Obinutuzumab plus Venetoclax (GVe)
D. Obinutuzumab plus Ibrutinib plus Venetoclax (GIVe)

Patient Profile

Chronic Lymphocytic Leukaemia (CLL) without del17p or TP53 mutation who have not been treated.

Where’s this trial being run?

Beaumont Hospital, Cork University Hospital, St James’s Hospital, University Hospital Galway, University Hospital Waterford, 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: CLL13
Number: 16-60
Full Title:

A phase 3 multicenter, randomized, prospective, open-label trial of standard chemoimmunotherapy (FCR/BR) versus rituximab plus venetoclax (RVe) versus obinutuzumab (GA101) plus venetoclax (GVe) versus obinutuzumab plus ibrutinib plus venetoclax (GIVe) in fit patients with previously untreated chronic lymphocyt-ic leukemia (CLL) without del(17p) or TP53 mutation.

Principal Investigator: Prof Patrick Thornton (Beaumont Hospital)
Type: Collaborative
Sponsor:

University of Cologne

Recruitment Started: Global: December 2016
Ireland: August 2017
Global Recruitment Target: 960
Ireland Recruitment Target: 30