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| Sponsor: | PETHEMA Foundation |
|---|---|
| Information provided by: | PETHEMA Foundation |
| ClinicalTrials.gov Identifier: | NCT00390897 |
Purpose
To compare the complete cytogenetic response rate in patients with newly-diagnosed chronic-phase chronic myeloid leukaemia treated with Glivec® alone or in combination with interferon at low doses
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukaemia |
Drug: Glivec Drug: Interferon |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomised Multicentre Phase IV Study to Compare Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec® in Combination With Interferon Alpha at Low Doses in the Treatment of Newly-Diagnosed Chronic-Phase Chronic Myeloid Leukaemia |
| Estimated Enrollment: | 360 |
| Study Start Date: | July 2003 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Open, prospective, multicentre, phase IV, comparative and randomised study
Eligibility| Ages Eligible for Study: | 18 Years to 72 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Spain | |
| Hospital general de Jerez de la Frontera | |
| Jerez de la Frontera, Spain | |
| Hospital San Pedro de Alcántara | |
| Cáceres, Spain | |
| Hospital comarcal de Valdeorras | |
| O'Barco de Valdeorras, Spain | |
| Hospital Ntra. Sra. Sonsoles | |
| Avila, Spain | |
| Hospital Clínic | |
| Barcelona, Spain | |
| Hospital Sant pau | |
| Barcelona, Spain | |
| Institut Català d'oncología | |
| Barcelona, Spain | |
| Hospital Universitario "Germans Trias i Pujol" | |
| Barcelona, Spain | |
| Hospital vall d'Hebrón | |
| Barcelona, Spain | |
| Hospital del Mar | |
| Barcelona, Spain | |
| Complejo Hospitalario Reina Sofía | |
| Córdoba, Spain | |
| Hospital Ruiz de Alda | |
| Granada, Spain | |
| Hospital Universitario Morales Meseguer, Murcia | |
| Murcia, Spain | |
| Hospital Médico Quirúrgico Ciudad de Jaén | |
| Jaen, Spain | |
| Hospital Juan Canalejo | |
| La Coruña, Spain | |
| Hospital Arnau de Vilanova | |
| Lleida, Spain | |
| Hospital Clínico San Carlos de Madrid | |
| Madrid, Spain | |
| Hospital Ramón y Cajal | |
| Madrid, Spain | |
| Clínica La Concepción | |
| Madrid, Spain | |
| Hospital Doce de Octubre | |
| Madrid, Spain | |
| Clínica Puerta de Hierro | |
| Madrid, Spain | |
| Hospital Universitario Princcipe de Asturias | |
| Madrid, Spain | |
| Hospital Gregorio Marañón | |
| Madrid, Spain | |
| Hospital de Fuenlabrada | |
| Madrid, Spain | |
| Hospital Juan Ramón Jiménez | |
| Huelva, Spain | |
| . Hospital Clínico Universitario Virgen de la Victoria | |
| Málaga, Spain | |
| Hospital Carlos Haya | |
| Málaga, Spain | |
| Hospital del Río Carrión | |
| Palencia, Spain | |
| Hospital Clínico Universitario de Salamanca | |
| Salamanca, Spain | |
| Hospital Universitario Marqués de Valdecilla | |
| Santander, Spain | |
| Hospital General | |
| Segovia, Spain | |
| Hospital Universitario Virgen del Rocío | |
| Sevilla, Spain | |
| Hospital Xeral | |
| Vigo, Spain | |
| Hospital Universitario la Fe | |
| Valencia, Spain | |
| Hospital Clínico Universitario | |
| Valencia, Spain | |
| Hospital General Universitario | |
| Valencia, Spain | |
| Hospital dr. Peset | |
| Valencia, Spain | |
| Hospital Joan XXIII | |
| tarragona, Spain | |
| Hospital Meixoeiro | |
| Vigo, Spain | |
| Hospital Virgen de la Concha | |
| Zamora, Spain | |
| Spain, Asturias | |
| Hospital Central de Asturias | |
| Oviedo, Asturias, Spain | |
| Spain, Barcelona | |
| Hospital Mútua de Terrassa | |
| Terrassa, Barcelona, Spain | |
| Corporació Sanitària Parc Taulí | |
| Sabadell, Barcelona, Spain | |
| Hospital de Mataró | |
| Mataró, Barcelona, Spain | |
| Spain, Canarias | |
| Hospital Universitario de Canarias | |
| Tenerife, Canarias, Spain | |
| Spain, Illes balears | |
| Hospital Son Dureta | |
| Palma de Mallorca, Illes balears, Spain | |
| Spain, Madrid | |
| Hospital de Alcorcón | |
| Alcorcón, Madrid, Spain | |
| Spain, Mallorca | |
| Hospital Son Llatzer | |
| Palma de Mallorca, Mallorca, Spain | |
| Spain, Navarra | |
| Clínica Universitaria de Navarra | |
| Pamplona, Navarra, Spain | |
| Hospital de Navarra | |
| Pamplona, Navarra, Spain | |
| Spain, Tarragona | |
| Hospital Verge de la Cinta | |
| Tortosa, Tarragona, Spain | |
| Study Chair: | Cervantes Francisco, Dr | Hospital Clínic Barcelona |
More Information
| Responsible Party: | pethema ( Pethema ) |
| Study ID Numbers: | LMC/PETHEMA, 03-0289 |
| Study First Received: | October 20, 2006 |
| Last Updated: | November 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00390897 History of Changes |
| Health Authority: | Spain: Ministry of Health |
|
chronic myeloid leukaemia Glivec Interferon |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Chronic-Phase Protein Kinase Inhibitors Leukemia Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Interferon-alpha Neoplasms by Histologic Type Hematologic Diseases |
Growth Substances Interferons Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Imatinib Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Interferon Alfa-2a Bone Marrow Diseases |