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Sponsors and Collaborators: |
University of Bologna Novartis |
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Information provided by: | University of Bologna |
ClinicalTrials.gov Identifier: | NCT00276926 |
The purpose of this study is to assess the clinical anti-proliferative activity of STI571 (Glivec®, Novartis,
Pharma) in patients with HES defined as:
Myeloproliferative disorder (MPD) with eosinophilia, eosinophilic leukemia or chronic myelomonocytic leukemia [myeloproliferative disorders/myelodysplastic syndromes (MPD/MDS)] with evidence of:
Condition | Intervention | Phase |
---|---|---|
Hypereosinophilic Syndrome Chronic Eosinophilic Leukemia (CEL) Myeloproliferative Disorders |
Drug: STI571 |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open Label Pilot Phase II Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment:
Contact: Giovanni Martinelli, MD | +39 051 6363829 | gmartino@alma.unibo.it |
Contact: Livia Galletti, PhD | +39 051 6363829 | acute@med.unibo.it |
Italy | |
Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna | Recruiting |
Bologna, Italy, 40138 | |
Principal Investigator: Giovanni Martinelli, MD | |
Sub-Investigator: Michela Rondoni, MD | |
Sub-Investigator: Pier Paolo Piccaluga, MD, PhD | |
Sub-Investigator: Stefania Paolini, MD | |
Dipartimento di Medicina Interna - Università di Genova | Recruiting |
Genova, Italy, 16100 | |
Contact: Marco Gobbi, MD +39 010 3532395 gobbi@unige.it | |
Principal Investigator: Marco Gobbi, MD | |
Dipartimento di Biochimica e Biotecnologie Mediche - Università degli Studi di Napoli "Federico II" | Recruiting |
Napoli, Italy, 80131 | |
Contact: Fabrizio Pane, MD + 39 081 7463135 fabpane@unina.it | |
Principal Investigator: Fabrizio Pane, MD | |
Divisione di Ematologia - Università degli Studi di Napoli "Federico II" | Recruiting |
Napoli, Italy, 80131 | |
Contact: Lucio Catalano, MD + 39 081 7462068 lcatalan@unina.it | |
Principal Investigator: Bruno Rotoli, MD | |
Sub-Investigator: Lucio Catalano, MD | |
Divisione di Ematologia - IRCCS Policlinico S. Matteo | Recruiting |
Pavia, Italy, 27100 | |
Contact: Serena Merante, MD +39 0382502250 s.merante@smatteo.pv.it | |
Principal Investigator: Mario Lazzarino, MD | |
Sub-Investigator: Serena Merante, MD | |
U.O. Ematologia - Dipartimento di Oncologia ed Ematologia, Presidio Ospedaliero di Ravenna | Recruiting |
Ravenna, Italy, 48100 | |
Contact: Eliana Zuffa, MD +39 0544285752 e.zuffa@ausl.ra.it | |
Principal Investigator: Alfonso Zaccaria, MD | |
Sub-Investigator: Eliana Zuffa, MD | |
U.O. Ematologia - Arcispedale Santa Maria Nuova | Recruiting |
Reggio Emilia, Italy, 42100 | |
Contact: Paolo Avanzini, MD +39 0522296681 paolo.avanzini@asmn.re.it | |
Principal Investigator: Luigi Gugliotta, MD | |
Sub-Investigator: Paolo Avanzini, MD | |
Clinica Ematologica - Policlinico Universitario | Recruiting |
Udine, Italy, 33100 | |
Contact: Mario Tiribelli, MD +39 0432559662 mtiribelli@hotmail.com | |
Principal Investigator: Renato Fanin, MD | |
Sub-Investigator: Mario Tiribelli, MD | |
Cattedra di Ematologia - Università "La Sapienza" | Recruiting |
Roma, Italy, 00161 | |
Contact: Giuliana Alimena, MD +39 06857951 alimena@bce.med.uniroma1.it | |
Principal Investigator: Franco Mandelli, MD | |
Sub-Investigator: Giuliana Alimena, MD | |
Divisione di Ematologia - Casa Sollievo della Sofferenza | Recruiting |
San Giovanni Rotondo, Italy, 71013 | |
Contact: Pellegrino Musto, MD +39 0882410539 p.musto@tin.it | |
Principal Investigator: Angelo Michele Carella, MD | |
Sub-Investigator: Pellegrino Musto, MD | |
U.O.C. Ematologia e Trapianti - Policlinico "Le Scotte" | Recruiting |
Siena, Italy, 53100 | |
Contact: Monica Bocchia, MD +39 0577586798 bocchia@unisi.it | |
Principal Investigator: Francesco Lauria, MD | |
Sub-Investigator: Monica Bocchia, MD | |
S.C. Medicina Interna II ed Ematologia - Laboratorio di Medicina Interna e Molecolare - A.O. San Luigi | Recruiting |
Orbassano, Italy, 10043 | |
Contact: Emanuela Messa, MD +39 0119026721 emanuelamessa@yahoo.it | |
Contact: Daniela Cilloni, MD +39 0119026610 daniela.cilloni@unito.it | |
Principal Investigator: Giuseppe Saglio, MD | |
Sub-Investigator: Emanuela Messa, MD | |
Sub-Investigator: Daniela Cilloni, MD | |
U.O. Medicina II Divisione - Ospedale Santa Chiara | Recruiting |
Trento, Italy, 38100 | |
Contact: Paolo Vivaldi, MD +39 0461903307 paolo.vivaldi@tn.it | |
Principal Investigator: Mauro Pedrazzoli, MD | |
Sub-Investigator: Paolo Vivaldi, MD | |
Sub-Investigator: Silvia Cerù, MD | |
Sub-Investigator: Anna Guella, MD | |
Cattedra di Ematologia - Università "Tor Vergata" | Recruiting |
Roma, Italy, 00133 | |
Contact: Francesco Buccisano, MD +39 06 20902674 francesco.buccisano@uniroma2.it | |
Principal Investigator: Sergio Amadori, MD | |
Sub-Investigator: Francesco Buccisano, MD |
Principal Investigator: | Michele Baccarani, MD | Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna |
Study ID Numbers: | HES0203 |
Study First Received: | January 12, 2006 |
Last Updated: | November 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00276926 History of Changes |
Health Authority: | Italy: The Italian Medicines Agency; Italy: Ethics Committee |
Hypereosinophilic Syndrome Eosinophilic leukemias STI571 (Gleevec) PDGF receptor alpha |
Familiar hypereosinophilia Myeloproliferative disorder (MPD) with eosinophilia myeloproliferative disorders/myelodysplastic syndromes |
Imatinib Leukemia Preleukemia Hematologic Diseases Hypereosinophilic Syndrome Myelodysplastic Syndromes |
Myeloproliferative Disorders Idiopathic Hypereosinophilic Syndrome Leukocyte Disorders Bone Marrow Diseases Protein Kinase Inhibitors Eosinophilia |
Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Myeloproliferative Disorders Enzyme Inhibitors Leukocyte Disorders Protein Kinase Inhibitors Eosinophilia |
Pharmacologic Actions Imatinib Leukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Hypereosinophilic Syndrome Bone Marrow Diseases |