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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00461929
Other study ID # CST1571ACA10 GIST
Secondary ID
Status Terminated
Phase Phase 4
First received April 16, 2007
Last updated February 12, 2009
Start date February 2005
Est. completion date December 2008

Study information

Verified date April 2007
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 68
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- GIST patient on Imatinib for more than 12 months

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
bone marrow aspiration


Locations

Country Name City State
Canada Mount Sinai Hospital Toronto Ontario
Canada Princess Margaret Hospital Toronto Ontario

Sponsors (4)

Lead Sponsor Collaborator
University Health Network, Toronto Mount Sinai Hospital, Canada, Novartis, Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary ~ presence or absence of genetic abnormality as seen in CML patients on imatinib
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