Multicenter phase II study of plitidepsin in patients with relapsed/refractory non-Hodgkin's lymphoma

Vincent Ribrag, Dolores Caballero, Christophe Fermé, Emanuele Zucca, Reyes Arranz, Javier Briones, Christian Gisselbrecht, Gilles Salles, Alessandro M. Gianni, Henry Gomez, Carmen Kahatt, Claudia Corrado, Sergio Szyldergemajn, Sonia Extremera, Bernardo de Miguel, Martin Cullell-Young, Franco Cavalli

Research output: Contribution to journalArticlepeer-review


This phase II clinical trial evaluated the efficacy, safety and pharmacokinetics of plitidepsin 3.2 mg/m2 administered as a 1-hour intravenous infusion weekly on days 1, 8 and 15 every 4 weeks in 67 adult patients with relapsed/refractory aggressive non-Hodgkin's lymphoma. Patients were divided into two cohorts: those with non-cutaneous peripheral T-cell lymphoma (n=34) and those with other lymphomas (n=33). Efficacy was evaluated using the International Working Group criteria (1999). Of the 29 evaluable patients with non-cutaneous peripheral T-cell lymphoma, six had a response (overall response rate 20.7%; 95% confidence interval, 8.0%-39.7%), including two complete responses and four partial responses. No responses occurred in the 30 evaluable patients with other lymphomas (including 27 B-cell lymphomas). The most common plitidepsin-related adverse events were nausea, fatigue and myalgia (grade 3 in

Original languageEnglish
Pages (from-to)357-363
Number of pages7
Issue number3
Publication statusPublished - Mar 1 2013

ASJC Scopus subject areas

  • Hematology
  • Medicine(all)


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