Once-weekly ofatumumab in untreated or relapsed Waldenstrom's macroglobulinaemia: an open-label, single-arm, phase 2 study.

ABSTRACT:

Background

The development of more effective and safer treatments, especially non-chemotherapeutics, is needed for patients with Waldenström's macroglobulinaemia. The aim of the study was to assess the safety and clinical activity of intravenous ofatumumab monotherapy for untreated and relapsed Waldenström's macroglobulinaemia.

Methods

We did a phase 2, open-label, single-arm study at six centres (hospitals and cancer clinics) in the USA. Patients aged at least 18 years who were diagnosed with untreated or relapsed Waldenström's macroglobulinaemia and required treatment, received up to three cycles of weekly ofatumumab for 5 weeks. For cycle 1, patients received one of two treatment regimens. Group A received ofatumumab 300 mg during week 1 followed by 1000 mg during weeks 2

SUBMITTER: Furman RR 

PROVIDER: S-EPMC5484580 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature