Pilot study: A prospective, real-world, feasibility study testing a decreased frequency paradigm in treatment free
Siri Ravipati1, Waffa Bakheet1, Indryas Woldie2
1University of Windsor, Windsor Regional Cancer Centre, Windsor, Ontario N8W1L9, Canada.
Abstract:
Treatment Free Remission (TFR) is an established goal for patients with the diagnosis of chronic myeloid leukemia (CML). The purpose of this prospective feasibility pilot study was assessing a new, real-world paradigm for safely stopping TKI treatment by monitoring molecular response through PCR tests determining BCR::ABL levels every 6 weeks instead of the recommended 4-week intervals. A successful re-establishment of MMR after loss of TFR was the primary endpoint. Eligibility criteria for this study included maintaining major molecular response 4 log reduction (MMR4) for 2 years and a total of TKI therapy for 5 years. The primary endpoint was successful maintenance of ≥ MMR at 6 months. 18 patients were enrolled, 13 of the 18 participants maintained TFR, and all 5 patients regained MMR with resumption of TKI treatment. We demonstrated that this pilot study was feasible in a community setting using 6-week intervals. This study will be expanded to other sites using a 6-week testing interval.
