title: 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.
  
  
  
  www.clinicaltrials.gov (NCT00824265).
authors.affiliation: a Department of Hematology , Medical University of Lodz and Copernicus Memorial Hospital , Lodz , Poland.
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Robak
authors.affiliation: b Department of Hematology , Institute of Hematology and Transfusion Medicine , Warsaw , Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Warzocha
authors.affiliation: c Kidwai Memorial Institute of Oncology , Bangalore , India.|d HCG Curie Centre of Oncology , Bangalore , India.
authors.forename: K
authors.initials: K
authors.lastname: Govind Babu
authors.affiliation: e Makiivka City Hospital #2 of Donetsk Region , Makiivka , Ukraine.
authors.forename: Yaroslav
authors.initials: Y
authors.lastname: Kulyaba
authors.affiliation: f Department of Medical Oncology , Wrocław Medical University , Wrocław , Poland.
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Kuliczkowski
authors.affiliation: g Russian Research Institute of Hematology and Transfusiology , St. Petersburg , Russia.
authors.forename: Kudrat
authors.initials: K
authors.lastname: Abdulkadyrov
authors.affiliation: h Hospital Universitario de La Princesa, IIS-IP , Madrid , Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Loscertales
authors.affiliation: i Oncohematology Department , National Cancer Institute , Kiev , Ukraine.
authors.forename: Iryna
authors.initials: I
authors.lastname: Kryachok
authors.affiliation: j Medical University of Bialystok , Bialystok , Poland.
authors.forename: Janusz
authors.initials: J
authors.lastname: Kłoczko
authors.affiliation: k Khmelnytskyi Regional Hospital , Khmelnytskyi , Ukraine.
authors.forename: Grygoriy
authors.initials: G
authors.lastname: Rekhtman
authors.affiliation: l Department of Hematology , Janusz Korczak Hospital , Słupsk , Poland.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Homenda
authors.affiliation: a Department of Hematology , Medical University of Lodz and Copernicus Memorial Hospital , Lodz , Poland.
authors.forename: Jerzy Z
authors.initials: JZ
authors.lastname: Błoński
authors.affiliation: m Novartis , Uxbridge , UK.
authors.forename: Astrid
authors.initials: A
authors.lastname: McKeown
authors.affiliation: n GlaxoSmithKline , Collegeville , PA , USA.
authors.forename: Michele M
authors.initials: MM
authors.lastname: Gorczyca
authors.affiliation: n GlaxoSmithKline , Collegeville , PA , USA.
authors.forename: Jodi L
authors.initials: JL
authors.lastname: Carey
authors.affiliation: o Novartis, Research Triangle Park , Durham , NC , USA.
authors.forename: Chai-Ni
authors.initials: CN
authors.lastname: Chang
authors.affiliation: p Genmab , Copenhagen , Denmark.
authors.forename: Steen
authors.initials: S
authors.lastname: Lisby
authors.affiliation: q Novartis , King of Prussia , PA , USA.
authors.forename: Ira V
authors.initials: IV
authors.lastname: Gupta
authors.affiliation: r Department of Cancer Prevention, Faculty of Public Heath , Medical University of Silesia , Katowice , Poland.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Grosicki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D012008:Recurrence; D016896:Treatment Outcome; D014740:Vidarabine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003520:Cyclophosphamide; D014740:Vidarabine; C527517:ofatumumab; C024352:fludarabine
keywords: FC; Ofatumumab; chemoimmunotherapy; phase III clinical trial; relapsed CLL