NCT01678430

A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment

A Randomised Investigation of Alternative Ofatumumab-containing Regimens in Less Fit Patients With CLL

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 670 (estimated)
• Sponsor: University of Liverpool · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare ofatumumab \& chlorambucil (O-Chl) versus ofatumumab \& bendamustine (O-B) in patients with Chronic Lymphocytic Leukaemia who are considered not fit enough for rituximab, fludarabine \& cyclophosphamide (R-FC).

Detailed description

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.

Conditions

• Chronic Lymphocytic Leukaemia

Interventions

Type	Name	Description
DRUG	Ofatumumab
DRUG	Chlorambucil
DRUG	Bendamustine

Timeline

• Start date: 2011-12-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2012-09-05
• Last updated: 2012-10-15

Locations

28 sites across 1 country: United Kingdom