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Sponsored by: |
PETHEMA Foundation |
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Information provided by: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00390897 |
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
Ages Eligible for Study: | 18 Years to 72 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Cervantes Francisco, Dr | Hospital Clínic Barcelona |
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 |
Interferon-alpha Immunologic Factors Hematologic Diseases Interferons Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Protein Kinase Inhibitors |
Antiviral Agents Imatinib Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Bone Marrow Diseases Interferon Alfa-2a |
Interferon-alpha Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hematologic Diseases Physiological Effects of Drugs Interferons Myeloproliferative Disorders Enzyme Inhibitors |
Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase Protein Kinase Inhibitors Antiviral Agents Pharmacologic Actions Imatinib Leukemia Neoplasms Therapeutic Uses Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases |