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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
Show 51 Study Locations| Study Chair: | Cervantes Francisco, Dr | Hospital Clínic Barcelona |
More Information
| Responsible Party: | Pethema, pethema |
| ClinicalTrials.gov Identifier: | NCT00390897 History of Changes |
| Other Study ID Numbers: | LMC/PETHEMA, 03-0289 |
| Study First Received: | October 20, 2006 |
| Last Updated: | November 26, 2008 |
| Health Authority: | Spain: Ministry of Health |
|
chronic myeloid leukaemia Glivec Interferon |
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Interferon-alpha Interferon Alfa-2a Interferons Imatinib Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |