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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 (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 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 Social Bookmarking                   What's this? Submitted December 6, 2001 Accepted April 17, 2002 A phase II study of Imatinib Mesylate (Glivec TM)in Patients with Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoid Leukemias Oliver G Ottmann*, Brian J Druker, Charles L Sawyers, John M Goldman, Josy Reiffers, Richard T Silver, Sante Tura, Thomas Fischer, Michael Deininger, Charles A Schiffer, M Baccarani, Alois Gratwohl, Andreas Hochhaus, Dieter Hoelzer, Sofia Fernandes-Reese, I Gathmann, Renaud Capdeville, and Steve G O'Brien Medizinische Klinik III, Abt. Hamatologie / Onkologie, Johann Wolfgang Goethe Universitat, Frankfurt / Main, Germany Division of Hematology, Oregon Health Sciences University, Portland, OR,, USA Department of Medicine and Molecular Biology Institute, University of California at Los Angeles, Los Angeles, CA, USA Department of Haematology, Hammersmith Hospital/ICSM, London, UK, London, United Kingdom Laboratoire de Greffe de Moelle, Universite Victor Segalen, Bordeaux, France New York-Presbyterian Hospital Weill Medical College, Cornell University, New York, NY, USA Instituto di Ematologia, Ospedale Policlinico Sant'Orsola-Malpighi, Bologna, Italy Medizinische Klinik und Poliklinik, Universitatsklinikum, Mainz, Germany Abteilung Hamatologie/Onkologie, Universitat Leipzig, Leipzig, Germany Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA Division of Hematology, Udine University Hospital, Udine, Italy Division of Hematology, Universitatsklinik, Kantonspital, Basel, Switzerland Medizinische Universitatsklinik Mannheim, Universitat Heidelberg, Mannheim, Germany Novartis Pharma AG, Basel, Switzerland Department of Haematology, Royal Victoria Infirmary, University of Newcastle, Newcastle, United Kingdom * Corresponding author; email: ottmann{at}em.uni-frankfurt.de. Background: The translocation (9;22) gives rise to the p190Bcr-Abl and p210Bcr-Abl tyrosine kinase proteins considered sufficient for leukemic transformation. Philadelphia (Ph)-positive acute leukemia patients failing to respond to initial induction therapy have a poor prognosis with few effective treatment options. Imatinib mesylate (GlivecTM, formerly STI571) is an orally administered, potent inhibitor of the Bcr-Abl tyrosine kinase. Patients and Methods: We conducted a clinical trial in 56 patients with relapsed or refractory Ph-positive acute lymphoblastic leukemia (ALL; 48) or chronic myelogenous leukemia in lymphoid blast crisis (LyBC; 8). Imatinib was given once daily at 400mg or 600 mg. Results: Imatinib induced complete hematologic responses (CHR) and complete marrow responses (marrow-CR) 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. CHR were reported for 3 (38%) of the patients with LyBC (one sustained CHR). Grade 3 or 4 treatment related non-hematologic toxicity was reported for 9% patients; none of the patients discontinued therapy because of non-hematologic adverse reactions. Grade 4 neutropenia and thrombocytopenia occurred in 54% and 27% of patients. Conclusion: Imatinib therapy resulted in a clinically relevant hematologic response rate in relapsed or refractory Ph-positive 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. 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. 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