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

Primary Purpose

Chronic Myeloid Leukemia, Gastrointestinal Stromal Cell Tumors, Chromosome Abnormality

Status

Terminated

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

bone marrow aspiration

About this trial

This is an interventional diagnostic trial for Chronic Myeloid Leukemia focused on measuring chronic myeloid leukemia, gastrointestinal stromal cell tumors, chromosome abnormality, imatinib, bone marrow aspiration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

GIST patient on Imatinib for more than 12 months

Exclusion Criteria:

Sites / Locations

Mount Sinai Hospital
Princess Margaret Hospital

Outcomes

Primary Outcome Measures

~ presence or absence of genetic abnormality as seen in CML patients on imatinib

Secondary Outcome Measures

Full Information

NCT ID

NCT00461929

First Posted

April 16, 2007

Last Updated

February 12, 2009

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada, Mount Sinai Hospital, Canada, Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00461929

Brief Title

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

Acronym

GIST

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Terminated

Why Stopped

study terminated 12Feb09 due to low recruitment

Study Start Date

February 2005 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada, Mount Sinai Hospital, Canada, Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Myeloid Leukemia, Gastrointestinal Stromal Cell Tumors, Chromosome Abnormality

Keywords

chronic myeloid leukemia, gastrointestinal stromal cell tumors, chromosome abnormality, imatinib, bone marrow aspiration

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

68 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

bone marrow aspiration

Primary Outcome Measure Information:

Title

~ presence or absence of genetic abnormality as seen in CML patients on imatinib

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: GIST patient on Imatinib for more than 12 months Exclusion Criteria: nil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeff Lipton, MD

Organizational Affiliation

University Health Network, DMOH

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Martin Blackstein, MD

Organizational Affiliation

MOUNT SINAI HOSPITAL

Official's Role

Study Director

Facility Information:

Facility Name

Mount Sinai Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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