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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 28, 2006; DOI 10.1182/blood-2005-10-4073. This Article Full Text Full Text (PDF) Supplemental Document 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 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 Brune, M. Articles by Hellstrand, K. Search for Related Content PubMed PubMed Citation Articles by Brune, M. Articles by Hellstrand, K. Related Collections Neoplasia Immunotherapy Chemokines, Cytokines, and Interleukins Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 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 From the Departments of Hematology and Virology, University of Göteborg, Sweden; Hôpital de Versailles, Versailles, France; Monash Med C, Victoria, Australia; the Research Corporation Technologies, Tuscon, AZ; Charité-Universitätsmedizin, Berlin, Germany; the University of Heidelberg, Heidelberg, Germany; the British Columbia Cancer Agency, Vancouver, Canada; Helsingborg, Sweden; the Hadassah Hebrew-University Medical Center, Jerusalem, Israel; the Rambam Medical Center, Haifa, Israel; the Uppsala University Hospital, Uppsala, Sweden; Christchurch Hospital, Christchurch, New Zealand; the University of Pennsylvania Cancer Center, Philadelphia, PA; and the Royal Melbourne Hospital, Melbourne, Australia. The primary objective of this phase 3 study was to determine whether postconsolidation 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 twenty patients with AML (median age, 57 years; range, 18-84 years) were stratified by CR1 or subsequent CR (CR > 1) and randomly assigned to treatment with HDC/IL-2 or no treatment (control). Treatment comprised 10 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, sex, 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 < .01, log-rank test). For patients in CR1 (n = 261), treatment significantly improved LFS (P = .01) with 3-year LFS estimates of 40% (HDC/IL-2) compared with 26% (control). Side effects were typically mild to moderate. These results indicate that HDC/IL-2 treatment offers an efficacious and tolerable treatment for patients with AML in remission. (Blood. 2006;108:88-96) 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. 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