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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 (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 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 Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted January 2, 2008 Accepted April 11, 2008 Rituximab efficacy and safety in adult splenectomy candidates with chronic immune thrombocytopenic purpura - results of a prospective multicenter phase 2 study Bertrand Godeau*, Raphael Porcher, Olivier Fain, Francois Lefrere, Pierre Fenaux, Stephane Cheze, Anne Vekhoff, Marie-Paule Chauveheid, Jerome Stirnemann, Lionel Galicier, Emmanuelle Bourgeois, Stephanie Haiat, Bruno Varet, Michel Leporrier, Thomas Papo, Mehdi Khellaf, Marc Michel, and Philippe Bierling Medecine Interne, Hopital Henri-Mondor, Assistance Publique-Hopitaux de Paris, Universite Paris 12, Creteil, France Departement de Biostatistique et Informatique Medicale, Hopital Saint-Louis, Paris, France Medecine Interne, Hopital Jean-Verdier, Universite Paris 13, Bondy, France Universite Paris Descartes, Hematologie, Hopital Necker, Paris, France Hematologie, Hopital Avicenne, Universite Paris 13, Bobigny, France Hematologie, Hopital de la Cote-de-Nacre, Caen, France Hematologie, Hopital Hotel-Dieu, Paris, France Medecine Interne, Hopital Bichat, Paris, France Immunopathologie, Hopital Saint-Louis, Paris, France Hematologie, Hopital Huriez, Lille, France Etablissement Francais du Sang, Hopital Henri-Mondor, Creteil, France * Corresponding author; email: bertrand.godeau{at}hmn.aphp.fr. Whether rituximab could effectively and safely avoid splenectomy for adults with chronic immune thrombopenic 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 <30x109/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 50x109/L, 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) has sustained platelet counts 30x109/L without treatment. Thirty-six (60%) patients failed to respond; 25 of them 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. 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] Fresh Insights into Chronic Immune Thrombocytopenic Purpura Journal Watch Oncology and Hematology, September 23, 2008; 2008(923): 2 - 2. [Full Text]

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