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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) trial: study protocol for a phase II/III randomised controlled trial

Authors: Jamie B. Oughton, Laura Collett, Dena R. Howard, Anna Hockaday, Talha Munir, Kathryn McMahon, Lucy McParland, Claire Dimbleby, David Phillips, Andy C. Rawstron, Peter Hillmen

Published in: Trials | Issue 1/2017

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Abstract

Background

Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia. Achieving minimal residual disease (MRD) negativity in CLL is an independent predictor of survival even with a variety of different treatment approaches and regardless of the line of therapy.

Methods/design

GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) is a seamless phase II/III, multi-centre, randomised, controlled, open, parallel-group trial for patients with CLL who have recently responded to chemotherapy. Participants will be randomised to receive either obinutuzumab (GA-101) consolidation or no treatment (as is standard). The phase II trial will assess safety and short-term efficacy in order to advise on continuation to a phase III trial. The primary objective for phase III is to assess the effect of consolidation therapy on progression-free survival (PFS). One hundred eighty-eight participants are planned to be recruited from forty research centres in the United Kingdom.

Discussion

There is evidence that achieving MRD eradication with alemtuzumab consolidation is associated with improvements in survival and time to progression. This trial will assess whether obinutuzumab is safe in a consolidation setting and effective at eradicating MRD and improving PFS.

Trial registration

ISRCTN, 64035629. Registered on 12 January 2015.
EudraCT, 2014-000880-42. Registered on 12 November 2014.
Appendix
Available only for authorised users
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Metadata
Title
GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) trial: study protocol for a phase II/III randomised controlled trial
Authors
Jamie B. Oughton
Laura Collett
Dena R. Howard
Anna Hockaday
Talha Munir
Kathryn McMahon
Lucy McParland
Claire Dimbleby
David Phillips
Andy C. Rawstron
Peter Hillmen
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2107-0

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