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Chromosome Abnormalities in Chronic Myeloid Leukemia (CML) on Imatinib. GIST Patients on Imatinib (GIST)

This study has been terminated.
(study terminated 12Feb09 due to low recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461929
First Posted: April 18, 2007
Last Update Posted: February 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Princess Margaret Hospital, Canada
Mount Sinai Hospital, Canada
Novartis
Information provided by:
University Health Network, Toronto
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • ~ presence or absence of genetic abnormality as seen in CML patients on imatinib

Estimated Enrollment: 68
Study Start Date: February 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GIST patient on Imatinib for more than 12 months

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461929


Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 2M9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Mount Sinai Hospital, Canada
Novartis
Investigators
Principal Investigator: Jeff Lipton, MD University Health Network, DMOH
Study Director: Martin Blackstein, MD Mount Sinai Hospital, New York
  More Information

Responsible Party: Dr. Jeff Lipton, University Health Network, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00461929     History of Changes
Other Study ID Numbers: CST1571ACA10 GIST
First Submitted: April 16, 2007
First Posted: April 18, 2007
Last Update Posted: February 13, 2009
Last Verified: April 2007

Keywords provided by University Health Network, Toronto:
chronic myeloid leukemia
gastrointestinal stromal cell tumors
chromosome abnormality
imatinib
bone marrow aspiration

Additional relevant MeSH terms:
Chromosome Aberrations
Chromosome Disorders
Leukemia
Leukemia, Myeloid
Congenital Abnormalities
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Genetic Diseases, Inborn
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action