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Blood, 15 August 2008, Vol. 112, No. 4, pp. 999-1004. Prepublished online as a Blood First Edition Paper on May 7, 2008; DOI 10.1182/blood-2008-01-131029. This Article Full Text Full Text (PDF) All Versions of this Article: blood-2008-01-131029v1 112/4/999    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Godeau, B. Articles by Bierling, P. Search for Related Content PubMed PubMed Citation Articles by Godeau, B. Articles by Bierling, P. Related Collections Hemostasis, Thrombosis, and Vascular Biology Free Research Articles Clinical Trials and Observations Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Rituximab efficacy and safety in adult splenectomy candidates with chronic immune thrombocytopenic purpura: results of a prospective multicenter phase 2 study Bertrand Godeau1, Raphael Porcher2, Olivier Fain3, François Lefrère4, Pierre Fenaux5, Stéphane Cheze6, Anne Vekhoff7, Marie-Paule Chauveheid8, Jerôme Stirnemann3, Lionel Galicier9, Emmanuelle Bourgeois10, Stéphanie Haiat7, Bruno Varet4, Michel Leporrier6, Thomas Papo8, Mehdi Khellaf1, Marc Michel1, and Philippe Bierling1,11 1 Médecine Interne, Hôpital Henri-Mondor, Assistance Publique–Hôpitaux de Paris, Université Paris 12, Créteil; 2 Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, Paris; 3 Médecine Interne, Hôpital Jean-Verdier, Université Paris 13, Bondy; 4 Université Paris Descartes, Hématologie, Hôpital Necker, Paris; 5 Hématologie, Hôpital Avicenne, Université Paris 13, Bobigny; 6 Hématologie, Hôpital de la Cote-de-Nacre, Caen; 7 Hématologie, Hôpital Hôtel-Dieu, Paris; 8 Médecine Interne, Hôpital Bichat, Paris; 9 Immunopathologie, Hôpital Saint-Louis, Paris; 10 Hématologie, Hôpital Huriez, Lille; and 11 Établissement Français du Sang, Hôpital Henri-Mondor, Créteil, France Whether rituximab could effectively and safely avoid splenectomy for adults with chronic immune thrombocytopenic purpura (ITP) remains unresolved. A multicenter, prospective, open-label, single-arm, phase 2 trial was conducted to assess rituximab safety and efficacy in adult splenectomy candidates with chronic ITP. Sixty patients with chronic ( 6 months) ITP and platelet counts less than 30 x 109/L received a weekly intravenous infusion of rituximab (375 mg/m2) for 4 weeks. All other ITP treatments were stopped. A good response was defined as a platelet count 50 x 109/L or more, with at least a doubling of the initial value at 1 and 2 years after the first rituximab infusion. Patients who required another treatment during follow up were considered nonresponders. Sixteen patients experienced transient side effects that necessitated treatment discontinuation for only 1. Good 1-year responses were obtained in 40% of the patients (24/60 [95% confidence interval: 28%-52%]). At 2 years, 33.3% (20/60 patients) had good responses and 6.7% (4/60) had sustained platelet counts of 30 x 109/L or more without treatment. Thirty-six (60%) patients failed to respond; 25 underwent splenectomy. Based on these results, rituximab was an apparently safe and effective splenectomy-avoiding option in some adults with chronic ITP. This trial is registered at http://clinicaltrials.gov as NCT00225875 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: "Spare-spleen-uximab" for chronic ITP Theodore E. Warkentin and Donald M. Arnold Blood 2008 112: 925-926. [Full Text] [PDF] This article has been cited by other articles: F. Rodeghiero, R. Stasi, T. Gernsheimer, M. Michel, D. Provan, D. M. Arnold, J. B. Bussel, D. B. Cines, B. H. Chong, N. Cooper, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group Blood, March 12, 2009; 113(11): 2386 - 2393. [Abstract] [Full Text] [PDF] K. Kelly, M. Gleeson, and P. T. Murphy Slow responses to standard dose rituximab in immune thrombocytopenic purpura Haematologica, March 1, 2009; 94(3): 443 - 444. [Full Text] [PDF]

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