GOALS AND OBJECTIVES

Our goal is to test a new paradigm for stopping TKIs in CML patients.  This paradigm is one that will be more universally accessible for patients across Canada.  This pilot trial will be the basis of a larger trial in Ontario.  There are 19 cancer centers the size of Windsor and smaller in Ontario.  We estimate that 60% of Ontario's population is serviced by these 19 cancer centers, and that the majority of patients in these cancer centers have not yet had access to a stopping trial.  If this trial is successful, we plan to role this trial out to these other centers.  This proposal has been presented to a group of hematologists/ oncologists in Ontario who represent the medium and smaller sized cancer centers, and this concept had significant support.

Objectives

1.    Test the feasibility of the new paradigm, i.e., are physicians reliably able to follow patients closely enough (every 6 weeks) for the first seven months to ensure safe stopping. 
2.     Is the laboratory able to reliably deliver results with a six-week turn-around?
3.    To monitor for the loss of MMR by following patients every six weeks with PCR BCR-ABL for seven months after stopping TKI therapy.
4.    To monitor for the safety of stopping criteria and follow-up:  Document loss of MMR and ability to re-achieve deep molecular response.