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Prepublished online as a Blood First Edition Paper on May 24, 2002; DOI 10.1182/blood-2001-12-0181. This Article Full Text Full Text (PDF) All Versions of this Article: 2001-12-0181v1 100/6/1965    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 Ottmann, O. G. Articles by O'Brien, S. G. Search for Related Content PubMed PubMed Citation Articles by Ottmann, O. G. Articles by O'Brien, S. G. Related Collections Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  Blood, 15 September 2002, Vol. 100, No. 6, pp. 1965-1971 CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS A phase 2 study of imatinib in patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoid leukemias Oliver G. Ottmann, Brian J. Druker, Charles L. Sawyers, John M. Goldman, Jose Reiffers, Richard T. Silver, Sante Tura, Thomas Fischer, Michael W. Deininger, Charles A. Schiffer, Michele Baccarani, Alois Gratwohl, Andreas Hochhaus, Dieter Hoelzer, Sofia Fernandes-Reese, Insa Gathmann, Renaud Capdeville, and Stephen G. O'Brien From the Medizinische Klinik III, Johann Wolfgang Goethe Universität, Frankfurt, Germany; Division of Hematology, Oregon Health Sciences University, Portland; Department of Medicine and Molecular Biology Institute, University of California at Los Angeles; Department of Haematology, Hammersmith Hospital/Imperial College School of Medicine, London, United Kingdom; Laboratoire de Greffe de Moelle, Université Victor Segalen, Bordeaux, France; New York-Presbyterian Hospital Weill Medical College of Cornell University, New York, NY; Instituto di Ematologia, Ospedale Policlinico Sant'Orsola-Malpighi, Bologna, Italy; Universitätsklinikum, 3 Medizinische Klinik und Poliklinik, Mainz, Germany; Abteilung Hämatologie/Onkologie, Universität Leipzig, Leipzig, Germany; Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI; Division of Hematology, Udine University Hospital, Udine, Italy; Division of Hematology, Universitätsklinik, Kantonspital, and Novartis Pharma, Basel, Switzerland; III Medizinische Universitätsklinik Mannheim der Universität Heidelberg, Mannheim, Germany; Department of Haematology, Royal Victoria Infirmary, University of Newcastle, United Kingdom. The translocation (9;22) gives rise to the p190Bcr-Abl and p210Bcr-Abl tyrosine kinase proteins, considered sufficient for leukemic transformation. Philadelphia-positive (Ph+) acute leukemia patients failing to respond to initial induction therapy have a poor prognosis with few effective treatment options. Imatinib is an orally administered, potent inhibitor of the Bcr-Abl tyrosine kinase. We conducted a clinical trial in 56 patients with relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL; 48 patients) or chronic myelogenous leukemia in lymphoid blast crisis (LyBC; 8 patients). Imatinib was given once daily at 400 mg or 600 mg. Imatinib induced complete hematologic responses (CHRs) and complete marrow responses (marrow-CRs) in 29% of ALL patients (CHR, 19%; marrow-CR, 10%), which were sustained for at least 4 weeks in 6% of patients. Median estimated time to progression and overall survival for ALL patients were 2.2 and 4.9 months, respectively. CHRs were reported for 3 (38%) of the patients with LyBC (one sustained CHR). Grade 3 or 4 treatment-related nonhematologic toxicity was reported for 9% of patients; none of the patients discontinued therapy because of nonhematologic adverse reactions. Grade 4 neutropenia and thrombocytopenia occurred in 54% and 27% of patients, respectively. Imatinib therapy resulted in a clinically relevant hematologic response rate in relapsed or refractory Ph+ acute lymphoid leukemia patients, but development of resistance and subsequent disease progression were rapid. Further studies are warranted to test the effects of imatinib in combination with other agents and to define the mechanisms of resistance to imatinib. © 2002 by The American Society of Hematology.   CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: Y. Chen, S. Agarwal, N. M. Shaik, C. Chen, Z. Yang, and W. F. 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