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632.O1.8 Chronic Myeloid Leukemia - Clinical Trials I

Monday, December 8, 2008: 7:00 AM-9:00 AM
Halls B and C (Moscone Center)
Moderators:
Martina Trinkaus and Rudiger Hehlmann
7:00 AM
High and Early Rates of Cytogenetic and Molecular Response with Nilotinib 800 Mg Daily as First Line Treatment of Ph-Positive Chronic Myeloid Leukemia in Chronic Phase: Results of a Phase 2 Trial of the GIMEMA CML Working Party

Gianantonio Rosti1*, Fausto Castagnetti1*, Angela Poerio1*, Massimo Breccia2*, Luciano Levato3*, Adele Capucci4*, Mario Tiribelli5*, Fabio Stagno6*, Alfonso Zaccaria7*, Tamara Intermesoli8*, Bruno Martino9*, Monica Bocchia10*, Michele Cedrone11*, Francesco Bartucci12*, Francesca Palandri1*, Gabriele Gugliotta1*, Nicoletta Testoni1*, Giuliana Alimena13, Giovanni Martinelli1*, Fabrizio Pane, MD14, Giuseppe Saglio15* and Michele Baccarani1*

1Institute of Hematology Seragnoli, Bologna, Bologna, Italy
2University of Rome – La Sapienza, Italy
3Hematology Unit, Catanzaro, Italy
4Hematology Unit, Brescia, Italy
5Chair of Hematology, Udine, Italy
6Chair of Hematology, Catania, Italy
7Ematologia-Ravenna, Italy
8Chair of Hematology, Bergamo, Italy
9Reggio Calabria Hospital
10Chair of Hematology, University of Siena, Italy
11Hematology Unit, "San Giovanni-Addolorata" Hospital, Roma, Italy
12Novartis Pharma, Origgio (VA), Italy
13Division of Hematology-Dept. of Cellular Biotechnologies and Hematology, University La Sapienza of Rome, Rome, Italy
14A.F. di Oncologia Ematologica Diagnostica, Azienda Ospedaliera, Napoli, Italy
15Internal Medicine and Hematology, Università di Torino - Ospedale San Luigi, Orbassano, Italy

7:15 AM
Efficacy of Dasatinib in Patients (pts) with Previously Untreated Chronic Myelogenous Leukemia (CML) in Early Chronic Phase (CML-CP)

Jorge Cortes, Susan O'Brien*, Gautam Borthakur*, Dan Jones*, Farhad Ravandi*, Charles Koller*, Ofelia Mesina*, Alessandra Ferrajoli*, Jianqin Shan* and Hagop Kantarjian*

M.D. Anderson Cancer Center, Houston, TX

7:30 AM
Randomized Comparison of Imatinib Versus Imatinib Combination Therapies in Newly Diagnosed Chronic Myeloid Leukaemia (CML) Patients in Chronic Phase (CP): First Results of the Phase III (SPIRIT) Trial from the French CML Group (FI LMC)

Francois Guilhot, MD1, François-Xavier Mahon, MD, PhD2*, Joelle Guilhot, MSci1*, Francoise Rigual-Huguet, MD3*, Frederic Maloisel, MD4*, Philippe Rousselot, MD, PhD5*, Martine Gardembas, MD6*, Selim Corm, MD7*, Agnes Guerci, MD, PhD8*, Anne Vekhoff, MD9*, Gabriel Etienne, MD10*, Laurence Legros, MD11*, Jean-Jacques Kiladjian, MD, PhD12*, Eric Jourdan13*, Michele Schoenwald, MD14*, Marc Berger, MD15*, Virginie Eclache, MD16*, Catherine Roche-Lestienne, PhD17*, Franck E Nicolini, MD, PhD18 and Claude Preudhomme, MD, PhD19

1Cic 802 Inserm, CHU de Poitiers, Poitiers, France
2Université Victor Ségalen Bordeaux - Institut Bergonié, Bordeaux, France
3Hopital Purpan, Toulouse, France
4Centre de Strasbourg, France
5Hôpital Mignot and CIC9504, Versaille, France
6Haematology, CHU Angers, Angers, France
7Hematology department, Hôpital Huriez, Lille, France
8CHU Brabois, Nancy, France
9Hotel Dieu, Paris, France
10Hematopiese leucemique, Universite Victor Segalen INSERM U876, Bordeaux, France
11Hematology department, Hôpital de l'Archet, Nice, France
12Hématologie Clinique, Assistance Publique - Hôpitaux de Paris, Hôpital Avicenne; Paris 13 University, Bobigny, France
13CHU de Nimes, Nimes, France
14Hopital La Source, Orleans, France
15CHU Hotel Dieu, Clermont Ferrant, France
16Hopital Avicenne
17Inserm U524, Lille, France
18Hematology Department, Hospital E. Herriot, Lyon, France
19Hopital Calmette, Lille, France

7:45 AM
Randomized Comparison of Imatinib 400 Mg Vs. Imatinib + IFN Vs. Imatinib + AraC Vs. Imatinib after IFN Vs. Imatinib 800 Mg: Optimized Treatment and Survival. Designed First Interim Analysis of the German CML Study IV

Ruediger Hehlmann, MD1, Susanne Saussele, MD1*, Michael Lauseker2*, Ulrike Proetel, MD1*, Elena Kovalevskaya, MD1*, Armin Leitner, MD1*, Claudia Haferlach, MD3*, Brigitte Schlegelberger, MD4, Martin C Müller, MD1*, Benjamin Hanfstein, MD1*, Markus Pfirrmann, PhD2*, Gerhard Ehninger5, Thomas Fischer, MD6*, Joerg Hasford, MD2*, Andreas Hochhaus, MD1*, Dieter K. Hossfeld, MD, PhD7*, Hans- Jochem Kolb, MD8*, Stefan W Krause, MD9*, Christoph Nerl, MD10*, Hans Pralle, MD11*, Alois Gratwohl12, Andreas Tobler, MD13, Hermann Heimpel, MD14* and The German CML Study Group15*

1Medical Faculty Mannheim, University Heidelberg, Mannheim, Germany
2IBE University, München, Germany
3MLL, München, Germany
4Inst. of Cell & Molecular Pathology, MHH, Hannover, Germany
5Medical Clinic I, University Hospital, Dresden, Germany
63. Medizinische Klinik, University, Mainz, Germany
7Onkologische Schwerpunktpraxis Lerchenfeld, Hamburg, Germany
8Transplantationseinheit, University, München, Germany
9Medizinische Klinik 5, Universitätsklinikum, Erlangen, Germany
10Krankenhaus Schwabing, München, Germany
11Medizinische Klinik IV, Giessen, Germany
12University Hospital Basel, Basel, Switzerland
13Department of Hematology, Inselspital, Bern, Switzerland
14Medizinische Universitätsklinik und Poliklinik, University, Ulm, Germany
15Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany

8:00 AM
Cytogenetic and Molecular Response to Imatinib in High Risk (Sokal) Chronic Myeloid Leukemia (CML): Results of An European Leukemianet Prospective Study Comparing 400 Mg and 800 Mg Front-Line

Michele Baccarani1, Fausto Castagnetti2*, Bengt Simonsson3*, Kimmo Porkka4*, Ibrahim C. Haznedaroglu5*, Arnon Nagler6, Francesca Palandri2*, Giovanna Rege Cambrin7*, Luciano Levato8*, Fausto Palmieri9*, Elisabetta Abruzzese10, Ugur Özbek11*, Veli Kairisto12*, Hans Bostrom3*, Johann Lanng Nielsen13*, Henrik Hjorth-Hansen14*, Ole Weis-Bjerrum15*, Nicoletta Testoni2*, Giovanni Martinelli16*, Fabrizio Pane, MD17, Giuseppe Saglio7* and Gianantonio Rosti2*

1Department of Hematology and Oncological Sciences, University of Bologna, Bologna, Italy
2Dept. Hematology and Medical Oncology, University of Bologna, Bologna, Italy
3Hematology Unit, Uppsala University, Uppsala, Sweden
4Helsinki University Central Hospital, Helsinki, Hematology Research Unit, Finland
5Hematology, Hacettepe University, Ankara, Turkey
6Division of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel Hashomer, Israel
7Internal Medicine and Hematology, Università di Torino - Ospedale San Luigi, Orbassano, Italy
8Hematology Unit, Catanzaro, Italy
9Hematology Unit, Avellino, Italy
10S. Eugenio Hospital, Rome, Italy
11Instanbul University, Instanbul, Turkey
12Turku University Central Hospital, Department of Medicine, Turku, Finland
13Aarhus University Hospital, Aarhus, Denmark
14St Olavs University Hospital, Trondheim, Norway
15Hematology Unit, Rigshospitalet, Copenhagen, Denmark
16Department of Hematology and Oncological Sciences, Seragnoli Institute, University of Bologna, Bologna, Italy
17A.F. di Oncologia Ematologica Diagnostica, Azienda Ospedaliera, Napoli, Italy

8:15 AM
International Randomized Study of Interferon Versus STI571 (IRIS) 7-Year Follow-up: Sustained Survival, Low Rate of Transformation and Increased Rate of Major Molecular Response (MMR) in Patients (pts) with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Treated with Imatinib (IM)

Stephen G O'Brien, MD, PhD1*, François Guilhot, MD2, John M Goldman, DM, FRCP3*, Andreas Hochhaus, MD4, Timothy P Hughes, MD5*, Jerald P. Radich, MD6*, Marc Rudoltz, MD7, Jeiry Filian7*, Insa Gathmann, M.Sc.8*, Brian J. Druker, MD9 and Richard A. Larson, MD10

1Department of Haematology, University of Newcastle, Newcastle, United Kingdom
2Clinical Investigational Centre INSERM 802, CHU Poitiers, Poitiers, France
3Department of Hematology, Imperial College London, Hammersmith Hospital, London, United Kingdom
4Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany
5Haematology, Institute of Medical and Veterinary Science, Adelaide, Australia
6Fred Hutchinson Cancer Research Ctr., Seattle, WA
7Oncology, Novartis Pharmaceutical, Inc., Florham Park, NJ
8Novartis Pharma AG, Basel, Switzerland
9Oregon Health & Science University Cancer Institute, Portland, OR
10University of Chicago, Chicago, IL

8:30 AM
Is It Possible to Stop Imatinib in Patients with Chronic Myeloid Leukemia? An Update from a French Pilot Study and First Results from the Multicentre « Stop Imatinib » (STIM) Study

Francois-Xavier Mahon1*, Francoise Huguet, MD2*, Francois Guilhot, MD3, Laurence Legros, MD, PhD4*, Franck E Nicolini, MD, PhD5, Aude Charbonnier6*, Agnes Guerci, MD7*, Delphine Rea, MD, PhD8*, Bruno R. Varet, MD9, Martine Gardembas, MD10*, Joelle Guilhot3*, Gabriel Etienne11*, Noel-Jean Milpied, MD, PhD12, Emilie Aton13*, Josy Reiffers11* and Philippe Rousselot14*

1Hématopoïèse leucémique, Université Victor Segalen CHU de Bordeaux, Bordeaux, France
2Service d'Hématologie, Hôpital Purpan, Toulouse, France
3Cic-P 802 Inserm, CHU de Poitiers, Poitiers, France
4Service d'Hématologie, Hôpital de l'Archet, Nice, France
5Hematology Department, Hospital E. Herriot, Lyon, France
6Institut Paoli Calmette, Marseille, France
7Service d'Hématologie, CHU Brabois, Nancy, France
8Service Des Maladies Du Sang, Hôpital Saint Louis, Paris, France
9Hematology Dept., Paris Descartes Univ. Necker Hospital, Paris, France
10Haematology, CHU Angers, Angers, France
11Institut Bergonié, Bordeaux, France
12Service des maladies du sang, Hopital Haut Leveque, Pessac, France
13Hopital Haut Leveque - Pessac, Bordeaux, France
14Centre André Mignot, Versaille, France

8:45 AM
Epidemiological Study on Survival of Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) Patients with T315I Mutation. Final Analysis

Franck E Nicolini, MD, PhD1, Giovanni Martinelli2*, Dong-Wook Kim, MD, PhD3, Andreas Hochhaus, MD4, Michael J. Mauro, MD5, Jorge Cortes, MD6, Charles Chuah, MBChB, MRCP, MD7*, Inge Dufva, MD8*, Jane F. Apperley, MBChB, FRCP, FRCPath9, Fumiharu Yagasaki, MD10*, Jay Pearson, PhD11*, Senaka Peter, MBA11*, Cesar Sanz Rodriguez, MD11*, Frank Giles, MD12*, John M Goldman, DM, FCRP, FRCPath13* and Wei Zhou, PhD11*

1Hematology Department, Hospital E. Herriot, Lyon, France
2Department of Hematology/Oncology “L. and A. Seràgnoli”, University of Bologna, Italy
3Hematology, St. Mary's Hospital, Seoul, South Korea
4Medizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany
5Oregon Health & Science University, Portland, OR
6M.D. Anderson Cancer Center, Houston, TX
7Hematology, Singapore General Hospital/Duke-NUS Graduate Medical School, Singapore, Singapore
8Department of Hematology, Herlev Hospital, University of Copenhagen, Herlev, Denmark
9Dept. of Haematology, Hammersmith Hospital, London, United Kingdom
10Japan Adult Leukemia Study Group, Japan
11Merck Research Laboratories, White house station, NJ
12Institute for Drug Development, Cancer Therapy & Research Center, San Antonio, TX
13Dept of Haematology, Hammersmith hospital, London, United Kingdom

*signifies non-member of ASH