Ignite Creation Date:
2024-05-05 @ 10:54 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01215487
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2010-10-04
Brief Title:
A Study Investigating the Predictive Value of Philadelphia Positive Stem Cell Properties in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase Receiving Treatment With Imatinib
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Study Investigating the Predictive Value of Philadelphia Positive Stem Cell Properties in Newly Diagnosed Patients With Chronic Myeloid in Chronic Phase Receiving Treatment With Imatinib
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Imatinib IM is first-line treatment for patients with newly diagnosed CML in chronic phase The drug is associated with high rates of cytogenetic responses with minimal toxicity in approximately 80 of patients In 20 of patients however the disease is either initially unresponsive to IM Imatinib resistance develops within a few months or blast crisis occurs early and unexpectedly following an initial response An increasing body of clinical evidence indicates that single agent molecularly targeted therapy as in GleevecImatinib will not cure most patients with CML as molecular remissions are rare There is currently no clinically useful predictive tests to identify AT DIAGNOSIS those patients who are destined to be IM failures The authors of this study have recently demonstrated that CML stemprogenitor cells are biologically insensitive to IM and are also genetically unstable and rapidly generate IM-resistant mutants in vitro and in vivo The team recently discovered that the CD34 stemprogenitor cells of newly diagnosed CML patients who subsequently fail to respond to IM treatment show a reduced response to IM and a higher frequency of BCR-ABL mutations by comparison of 14 IM non-responders with 11 IM-responders If this finding can be validated in a larger prospective cohort of patients this predictive test could be used to more rationally design treatment plans with early addition of alternative therapies ie Dasatinib or combination therapies for patients according to their individual risk profiles
Hypothesis
The clinical response of newly diagnosed chronic phase CML patients to IM can be predicted by certain biological properties of their CD34 stemprogenitor cells which are variable among patients
Hypothesis
The clinical response of newly diagnosed chronic phase CML patients to IM can be predicted by certain biological properties of their CD34 stemprogenitor cells which are variable among patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None