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

This study has been terminated.
(study terminated 12Feb09 due to low recruitment)
Sponsor:
Collaborators:
Princess Margaret Hospital, Canada
Mount Sinai Hospital, Canada
Novartis
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00461929
First received: April 16, 2007
Last updated: February 12, 2009
Last verified: April 2007
History of Changes
  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: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GIST patient on Imatinib for more than 12 months

Exclusion Criteria:

  • nil
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Jeff Lipton, University Health Network, Princess Margaret Hospital
ClinicalTrials.gov Identifier: NCT00461929     History of Changes
Other Study ID Numbers: CST1571ACA10 GIST
Study First Received: April 16, 2007
Last Updated: February 12, 2009
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on May 19, 2013