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Sponsors and Collaborators: |
Institut Bergonié Novartis |
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Information provided by: | Institut Bergonié |
ClinicalTrials.gov Identifier: | NCT00210119 |
Imatinib mesylate is standard treatment of Chronic myeloid leukaemia, complete cytogenetic response is obtained in most of cases but molecular response concerned only a small part of the patients. To increase molecular response ratio we decided to increase imatinib dose to limited resistance to this drug and to add zoledronate for it anti tumoral activity to increase anti leukemic effect. We plan to accrue 37 patients in 5 centers. We will analyse molecular expression of BCR-ABL transcript after 6 months of treatment, safety, duration of response, VEGF expression and LTgd production.
Condition | Intervention | Phase |
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Myeloid Leukemia, Chronic |
Drug: Imatinib mesylate and zoledronic acid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multicentric Phase II Study to Evaluate Feasibility and Efficacy of Association of Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response After One Year of Imatinib Mesylate Monotherapy |
Estimated Enrollment: | 37 |
Study Start Date: | September 2005 |
Study Completion Date: | October 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest | |
Bordeaux, France, 33076 | |
Centre Hospitalier Universitaire de Bordeaux | |
Bordeaux, France, 33076 | |
Centre Hospitalier Universitaire de Poitiers | |
Poitiers, France, 86000 | |
Hôpital Edouard Herriot | |
Lyon, France, 69437 | |
Hôpital Saint Louis | |
Paris, France, 75010 | |
Hôpital Archet | |
Nice, France, 06200 | |
Centre Hospitalier de Versailles | |
Le Chesnay, France, 78150 |
Principal Investigator: | Josy REIFFERS, Pr | Institut Bergonié |
Study ID Numbers: | IB2005-25, AFR22 |
Study First Received: | September 12, 2005 |
Last Updated: | October 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00210119 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Chronic myeloid leukemia imatinib mesylate zoledronate molecular response |
Imatinib Leukemia Diphosphonates Zoledronic acid Chronic myelogenous leukemia |
Hematologic Diseases Myeloproliferative Disorders Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Bone Marrow Diseases |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Bone Density Conservation Agents Protein Kinase Inhibitors Pharmacologic Actions |