Chronic Myeloid Leukemia Clinical Trial
Official title:
Treatment-free Remission Accomplished With Dasatinib in Patients With CML
The purpose of this study is to find out how to increase the potential for achieving an
"operational cure" from chronic myeloid leukemia. An "operational cure" is a state in which a
person does not require further treatment, although there may be some remaining cancer cells.
Patients would normally remain on a TK inhibitor indefinitely within a standard of care
setting for chronic myeloid leukemia. Within this clinical trial, patients will discontinue
their TK inhibitor prematurely. If any signs of progression are identified, dasatinib will be
introduced.
This research is being done because dasatinib has been shown to achieve a greater response in
a much higher proportion of patients as compared to imatinib. Dasatinib is approximately 300
times more potent than imatinib, and it is possible that a greater response can be achieved
by dasatinib than by imatinib.
This is an open label, single arm Phase II trial that will examine how safe and effective it
will be for patients with chronic myeloid leukemia (CML) to discontinued first line tyrosine
kinase inhibitor (TKI) therapy.
The main goal of this study is to determine the potential role of dasatinib (the study drug)
in helping patients with CML attain a sustained treatment free remission.
During this study the safety and tolerability of Dasatinib will be evaluated by means of drug
related toxicity, adverse event reports, physical examinations and laboratory safety
evaluations.
The study period for an individual patient is expected to be approximately between 30-72
months.
A total of 135 patients will be recruited from 10 Canadian centres.
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