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

Phase 3 Unknown 670 enrolled University of Liverpool Chugai Pharma USA · collab GlaxoSmithKline · collab Napp Pharmaceuticals Limited · collab

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2011-12
Primary completion: 2017-12
Completion: 2017-12

Publications

Lim YJ, Duckworth AD, Clarke K, Kennedy P, Karpha I, Oates M, Gornall M, Kalakonda N, Slupsky JR, Pettitt AR. Influence of polyfunctional Tbet+ T cells on specific clinical events in chronic lymphocytic leukaemia. Front Immunol. 2025 Apr 17;16:1528405. doi: 10.3389/fimmu.2025.1528405. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bendamustine	Small molecule	70 mg/m2	Intravenous
Comparator	Chlorambucil	Other / unclassified	10 mg/m2	Oral
Subject	Ofatumumab	Monoclonal antibody	1000 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications