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Blood, 1 July 2006, Vol. 108, No. 1, pp. 88-96. Prepublished online as a Blood First Edition Paper on March 23, 2006March 28, 2006; DOI 10.1182/blood-2005-10-4073. This Article Full Text (PDF) All Versions of this Article: 2005-10-4073v1 2005-10-4073v2 108/1/88    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 Brune, M. Articles by Hellstrand, K. Search for Related Content PubMed PubMed Citation Articles by Brune, M. Articles by Hellstrand, K. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted October 12, 2005 Accepted February 24, 2006 Improved leukemia-free survival after post-consolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase III trial Mats Brune*, Sylvie Castaigne, John Catalano, Kurt Gehlsen, Anthony D Ho, Wolf-Karsten Hofmann, Donna E Hogge, Bo Nilsson, Reuven Or, Ana I Romero, Jacob M Rowe, Bengt Simonsson, Ruth Spearing, Edward A Stadtmauer, Jeff Szer, Elisabeth Wallhult, and Kristoffer Hellstrand Departments of Hematology and Virology, University of Goteborg, Gothenburg, Sweden Hopital de Versailles, Paris, France Monash Med C, Victoria, Australia Research Corporation Technologies, Tuscon, USA University of Heidelberg, Heidelberg, Germany Charite-Universitatsmedizin, Berlin, Germany British Columbia Cancer Agency, Vancouver, Canada Helsingborg, Helsingborg, Sweden Hadassah Hebrew-University Medical Center, Jerusalem, Israel Rambam Medical Center, Haifa, Israel Uppsala University Hospital, Uppsala, Sweden Christchurch Hospital, Christchurch, New Zealand University of Pennsylvania Cancer Center, Philadelphia, PA, USA Royal Melbourne Hospital, Melbourne, Australia * Corresponding author; email: mats.brune{at}medfak.gu.se. The primary objective of this phase III study was to determine whether post-consolidation immunotherapy with interleukin-2 (IL-2) and histamine dihydrochloride (HDC) improved the leukemia-free survival (LFS) of adult patients with acute myeloid leukemia (AML) in complete remission (CR). Three hundred and twenty AML patients (median age 57 years, range 18-84) were stratified by CR1 or CR >1 and randomized to treatment with HDC/IL-2 or no treatment (control). Treatment comprised ten 21-day cycles with IL-2 (16,400 U/kg) plus HDC (0.5 mg); both compounds were administered by subcutaneous injection twice daily. Study arms were balanced for age, gender, previous treatment, leukemic karyotypes, time from CR to inclusion, and frequency of secondary leukemia. Three years after enrollment of the last patient, treatment with HDC/IL-2 was found to improve LFS over control in the study population (CR1 + CR >1, n=320, p< 0.01, Log Rank Test). For CR1 patients (n=261), treatment significantly improved LFS (p=0.01) with 3-year LFS estimates of 40% (HDC/IL-2) compared to 26% (control). Side effects were typically mild to moderate. These results indicate that HDC/IL-2 treatment offers an efficacious and tolerable treatment for AML patients in remission. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: E. L.J.M. Smits, Z. N. Berneman, and V. F.I. Van Tendeloo Immunotherapy of Acute Myeloid Leukemia: Current Approaches Oncologist, March 1, 2009; 14(3): 240 - 252. [Abstract] [Full Text] [PDF] T. Ando, K. Mimura, C. C. Johansson, M. G. Hanson, D. Mougiakakos, C. Larsson, T. Martins da Palma, D. Sakurai, H. Norell, M. Li, et al. Transduction with the Antioxidant Enzyme Catalase Protects Human T Cells against Oxidative Stress J. Immunol., December 15, 2008; 181(12): 8382 - 8390. [Abstract] [Full Text] [PDF] M. R. Baer, S. L. George, M. A. Caligiuri, B. L. Sanford, S. M. Bothun, K. Mrozek, J. E. Kolitz, B. L. Powell, J. O. Moore, R. M. Stone, et al. Low-Dose Interleukin-2 Immunotherapy Does Not Improve Outcome of Patients Age 60 Years and Older With Acute Myeloid Leukemia in First Complete Remission: Cancer and Leukemia Group B Study 9720 J. Clin. Oncol., October 20, 2008; 26(30): 4934 - 4939. [Abstract] [Full Text] [PDF] S. Okabe, T. Tauchi, and K. Ohyashiki Characteristics of Dasatinib- and Imatinib-Resistant Chronic Myelogenous Leukemia Cells Clin. Cancer Res., October 1, 2008; 14(19): 6181 - 6186. [Abstract] [Full Text] [PDF] M. Middleton, A. Hauschild, D. Thomson, R. Anderson, S. Burdette-Radoux, K. Gehlsen, K. Hellstrand, and P. Naredi Results of a multicenter randomized study to evaluate the safety and efficacy of combined immunotherapy with interleukin-2, interferon-{alpha}2b and histamine dihydrochloride versus dacarbazine in patients with stage IV melanoma Ann. Onc., October 1, 2007; 18(10): 1691 - 1697. 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