A Randomised Investigation of Alternative Ofatumumab-containing Regimens in Less Fit Patients With CLL
Chlorambucil (Chl) has been the mainstay of CLL treatment for half a century. However,
frontline treatment has improved considerably over the last decade, first by the advent of
fludarabine plus cyclophosphamide (FC), and more recently by the addition of the anti-CD20
antibody, rituximab, to FC. Although FC-based regimens are considerably more effective than
Chl, they are also associated with greater toxicity which makes them inappropriate for less
fit patients. This is an important consideration, given that CLL predominantly affects older
people who tend to have more co-morbidity. Although a single-arm phase II study (Roche
MO20927; NCRI CLL208) has shown that R-Chl is safe and effective, there are no phase III
data proving the benefit of adding an anti-CD20 antibody to Chl. This question is currently
being addressed by a phase III RCT of Chl with or without ofatumumab (GSK OMB110911 /
COMPLEMENT-1 / NCRI CLL7). Ofatumumab is a fully human anti-CD20 antibody that binds to an
epitope distinct from that of rituximab and produces more complement-dependent cytotoxicity.
The RIAltO trial is a direct follow-on to the NCRI CLL7 phase III RCT trial in less fit
patients and therefore the Ofatumumab dose has been selected to mirror the regimen used in
that trial.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Calculated from the date of randomisation to the date of progression or death, or the censor date.
There are three pre-planned analyses of the PFS primary endpoint: end recruitment (approx 150 events); 300 events (after a minimum 12 months follow up for all patients), 400 events (after a minimum 24 months follow up for all patients)
No
United Kingdom: Medicines and Healthcare Products Regulatory Agency
OMB114578
NCT01678430
December 2011
December 2017
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