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

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

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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.
Original languageEnglish
Article number353
Number of pages12
JournalTrials
Volume18
DOIs
Publication statusPublished - 26 Jul 2017

Keywords

  • Chronic lymphocytic leukaemia (CLL)
  • Obinutuzumab
  • GA-101
  • Consolidation
  • Phase II/III trial
  • Minimal residual disease (MRD)
  • Randomised controlled trial (RCT)

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