Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Completed NCT02057185 - Occupational Status and Hematological Disease
Recruiting NCT03326310 - Selumetinib and Azacitidine in High Risk Chronic Blood Cancers Phase 1
Recruiting NCT04621851 - Retro-prospective Observational Study on Risk of Progression in CP-CML Patients Eligible for TKI Discontinuation
Completed NCT01207440 - Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) Phase 2
Not yet recruiting NCT06409936 - PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML Phase 2
Active, not recruiting NCT02917720 - 2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients Phase 2
Not yet recruiting NCT02883036 - Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia N/A
Withdrawn NCT01188889 - RAD001 in Patients With Chronic Phase Chronic Myeloid Leukemia w/ Molecular Disease. Phase 1/Phase 2
Completed NCT01795716 - Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body Phase 1
Completed NCT00988013 - Intensity Modulated Total Marrow Irradiation (IM-TMI) for Advanced Hematologic Malignancies N/A
Approved for marketing NCT00905593 - Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Phase 3
Terminated NCT00573378 - Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia Phase 2
Terminated NCT00522990 - Study to Assess the Safety of Escalating Doses of AT9283, in Patients With Leukemias Phase 1/Phase 2
Completed NCT00469014 - Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia Phase 2
Completed NCT00257647 - Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML) N/A
Unknown status NCT00598624 - Clinical Trial to Evaluate the Safety and Efficacy of Treosulfan Based Conditioning Prior to Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) Phase 2
Completed NCT00219739 - STI571 ProspectIve RandomIzed Trial: SPIRIT Phase 3
Completed NCT06148493 - Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database
Completed NCT00375219 - Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation Phase 2