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| Sponsors and Collaborators: |
University Health Network, Toronto Princess Margaret Hospital, Canada Mount Sinai Hospital, Canada Novartis |
|---|---|
| Information provided by: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT00461929 |
Purpose
In order to distinguish between clonal instability driven by imatinib in CML and actual changes with secondary clones induced by imatinib we would like to investigate the karyotype of non-CML patients treated with imatinib such as GIST patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukemia Gastrointestinal Stromal Cell Tumors Chromosome Abnormality |
Procedure: bone marrow aspiration |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
| Official Title: | Are the Secondary Chromosome Abnormalities Seen in Chronic Myeloid Leukemia (CML) Cells Induced to Ph-Chromosome Negativity by Imatinib a Result of Chromosome Instability or a Side Effect of the Therapy – a Study in GIST (Gastrointestinal Stromal Cell Tumors) Patients Treated With Imatinib. |
| Estimated Enrollment: | 68 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | December 2008 |
Chronic myeloid leukemia (CML) is a myeloproliferative disorder characterized by the presence of the Philadelphia (Ph) chromosome - a t(9:22) translocation that results in the production of a BCR/ABL fusion protein with Abl kinase activity.
Imatinib mesylate (Gleevec) specifically targets a limited set of protein tyrosine kinases – ABL, Arg (Abl-related gene), c-Kit, platelet-derived growth factor receptor (PDGF-R) – and their oncogenic forms, most notably BCR/ABL Imatinib is also a potent inhibitor of a receptor-type c-Kit tyrosine kinase. Therefore imatinib was examined for therapeutic efficacy against malignant gastro-intestinal stromal tumors (GIST) Recent articles have drawn attention to the development of new Ph-negative, cytogenetically unrelated clones after therapy of Ph-positive CML with imatinib. Trisomy 8 and monosomy 7 are the most frequent defects, but other aberrations have also been reported. Some of these cytogenetic abnormalities are associated with acute myeloid leukemia and MDS.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lidia Casciaro, RN.BSc.N | 416-946-4501 ext 4706 | Lidia.Casciaro@uhn.on.ca |
| Canada, Ontario | |
| Mount Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Principal Investigator: | Jeff Lipton, MD | University Health Network, DMOH |
| Study Director: | Martin Blackstein, MD | MOUNT SINAI HOSPITAL |
More Information
| Study ID Numbers: | CST1571ACA10 GIST |
| Study First Received: | April 16, 2007 |
| Last Updated: | April 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00461929 |
| Health Authority: | Canada: Health Canada |
|
chronic myeloid leukemia gastrointestinal stromal cell tumors chromosome abnormality imatinib bone marrow aspiration |
|
Chromosomal abnormalities Chronic myelogenous leukemia Hematologic Diseases Chromosome Disorders Myeloproliferative Disorders Leukemia, Myeloid Imatinib |
Leukemia Genetic Diseases, Inborn Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasm Metastasis Chromosome Aberrations Congenital Abnormalities Bone Marrow Diseases |
|
Neoplasms Neoplasms by Histologic Type Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
