Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Institut Bergonié Novartis |
---|---|
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 |
---|---|---|
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:
· Other cancer excepted basocellular or cervix carcinoma · Major surgery in last 2 weeks previous inclusion· Women who are pregnant or breastfeeding (are unable to use an acceptable method to avoid pregnancy of his partner for the entire study period)· Dementia or altered mental status that would prohibit the understanding or rendering of informed consent · Abnormal renal function with creatinine clearance < 30 ml/ minuteAccording to Cockcroft-Gault : CrCl= [[140-age (years)] x weight (kg)]/ [72 x serum creatinine (mg/dL)] {x 0.85 for women}· Chronic myeloid leukaemia in acute phase or in pass to be in acute phase
hypersensitivity, on course dental problem, including tooth or mandibular infection; dental traumatism or recent diagnosis or previous mandibular osteonecrosis, or dental extraction with cicatrisation delay or necessity to set bone evidence · Mandibular surgery in last 6 weeks or planned in the future during treatment (tooth extraction)· Serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy: diabetes, thyroid pathology, neuropsychiatric illness, myocardial infarction or congestive heart failure grade 3-4 according to " New York Heart association"· History of psychiatric or depressive pathology · HIV positivity known · Inclusion in other study investigating antineoplastic molecule in last 30 days previous inclusion
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 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Chronic myeloid leukemia imatinib mesylate zoledronate molecular response |
Imatinib Leukemia Diphosphonates Zoledronic acid Hematologic Diseases Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Density Conservation Agents Chronic Myelogenous Leukemia Leukemia, Myeloid Bone Marrow Diseases Protein Kinase Inhibitors |
Neoplasms by Histologic Type Zoledronic acid Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Diseases Physiological Effects of Drugs Myeloproliferative Disorders Enzyme Inhibitors Bone Density Conservation Agents Leukemia, Myeloid |
Protein Kinase Inhibitors Pharmacologic Actions Imatinib Leukemia Neoplasms Diphosphonates Therapeutic Uses Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases |