Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial. Issue 5 (4th May 2017)

• Record Type: Journal Article
• Authors: Robak, Tadeusz; Warzocha, Krzysztof; Govind Babu, K.; Kulyaba, Yaroslav; Kuliczkowski, Kazimierz; Abdulkadyrov, Kudrat; Loscertales, Javier; Kryachok, Iryna; Kłoczko, Janusz; Rekhtman, Grygoriy; Homenda, Wojciech; Błoński, Jerzy Z.; McKeown, Astrid; Gorczyca, Michele M.; Carey, Jodi L.; Chang, Chai-Ni; Lisby, Steen; Gupta, Ira V.; Grosicki, Sebastian
• Is Part Of: Leukemia & lymphoma. Volume 58:Issue 5(2017)
• Page Start: 1084
• Page End: 1093
• Publication Date: 2017-05-04
• Subjects: Ofatumumab -- relapsed CLL -- chemoimmunotherapy -- FC -- phase III clinical trial; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.1080/10428194.2016.1233536
• Languages: English
• ISSNs: 1042-8194

Abstract

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).