Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia

William G. Wierda, Thomas J. Kipps, Jan Dürig, Laimonas Griskevicius, Stephan Stilgenbauer, Jiří Mayer, Lukáš Smolej, Georg Hess, Rasa Griniute, Francisco J. Hernandez-Ilizaliturri, Swaminathan Padmanabhan, Michele Gorczyca, Chai Ni Chang, Geoffrey Chan, Ira Gupta, Tina G. Nielsen, Charlotte A. Russell

Research output: Contribution to journalArticle

103 Scopus citations

Abstract

We conducted an international phase 2 trial to evaluate 2 dose levels of ofatumumab, a human CD20 mAb, combined with fludarabine and cyclophosphamide (O-FC) as frontline therapy for chronic lymphocytic leukemia (CLL). Patients with active CLL were randomized to ofatumumab 500 mg (n = 31) or 1000 mg (n = 30) day 1, with fludarabine 25 mg/m2 and cyclophosphamide 250 mg/m2 days 2-4, course 1; days 1-3, courses 2-6; every 4 weeks for 6 courses. The first ofatumumab dose was 300 mg for both cohorts. The median age was 56 years; 13% of patients had a 17p deletion; 64% had β2-microglobulin > 3.5 mg/L. Based on the 1996 National Cancer Institute Working Group (NCI-WG) guidelines, the complete response (CR) rate as assessed by an independent review committee was 32% for the 500-mg and 50% for the 1000-mg cohort; the overall response (OR) rate was 77% and 73%, respectively. Based on univariable regression analyses, β2-microglobulin and the number of O-FC courses were significantly correlated (P < .05) with CR and OR rates and progression-free survival (PFS). The most frequent Common Terminology Criteria (CTC) grade 3-4 investigator-reported adverse events were neutropenia (48%), thrombocytopenia (15%), anemia (13%), and infection (8%). O-FC is active and safe in treatment-naive patients with CLL, including high-risk patients. This trial was registered at www.clinicaltrials.gov as NCT00410163.

Original languageEnglish (US)
Pages (from-to)6450-6458
Number of pages9
JournalBlood
Volume117
Issue number24
DOIs
StatePublished - Jun 16 2011

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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