Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial

Abstract

In this multicenter, open-label, phase III study, patients with relapsed chronic lymphocytic leukemia (CLL) were randomized (1:1) to receive ofatumumab plus fludarabine and cyclophosphamide (OFA + FC) or FC alone; the primary endpoint being progression-free survival (PFS) assessed by an independent review committee (IRC). Between March 2009 and January 2012, 365 patients were randomized (OFA + FC: n = 183; FC: n = 182). Median IRC-assessed PFS was 28.9 months with OFA + FC versus 18.8 months with FC (hazard ratio = 0.67; 95% confidence interval, 0.51–0.88; p = .0032). Grade ≥3 adverse events (≤60 days after last dose) were reported in 134 (74%) OFA + FC-treated patients compared with 123 (69%) FC-treated patients. Of these, neutropenia was the most common (89 [49%] vs. 64 [36%]). OFA + FC improved PFS with manageable safety for patients with relapsed CLL compared with FC alone, thus providing an alternative treatment option for patients with relapsed CLL. Trial registration: www.clinicaltrials.gov (NCT00824265).

Keywords:

• Ofatumumab
• relapsed CLL
• chemoimmunotherapy
• FC
• phase III clinical trial

Acknowledgements

The authors would like to thank Sarah West for overseeing all operational aspects of the study and Declan McGuirk for his excellent management of the data.

We also thank Zoe Crossman, a medical writer, funded by Novartis Pharmaceuticals, for providing drafts and editorial assistance to the authors during preparation of this manuscript.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article online. at http://dx.doi.org/10.1080/10428194.2016.1233536.