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).

• Authors: Tadeusz Robak, Krzysztof Warzocha, K Govind Babu, Yaroslav Kulyaba, Kazimierz Kuliczkowski, Kudrat Abdulkadyrov, Javier Loscertales, Iryna Kryachok, Janusz Kłoczko, Grygoriy Rekhtman, Wojciech Homenda, Jerzy Z Błoński, Astrid McKeown, Michele M Gorczyca, Jodi L Carey, Chai-Ni Chang, Steen Lisby, Ira V Gupta, Sebastian Grosicki
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 58 Issue 5 Pg. 1084-1093 (05 2017) ISSN: 1029-2403 [Electronic] United States
• PMID: 27731748 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Cyclophosphamide
• Vidarabine
• ofatumumab
• fludarabine

Topics

• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (administration & dosage)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Cyclophosphamide (administration & dosage)
• Female
• Humans
• Kaplan-Meier Estimate
• Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy, mortality, pathology)
• Male
• Middle Aged
• Neoplasm Grading
• Neoplasm Staging
• Recurrence
• Treatment Outcome
• Vidarabine (administration & dosage, analogs & derivatives)