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This investigational combination therapy involves the administration of eicosapentaenoic acid (EPA), an omega-3 fatty acid, as an adjunct to standard tyrosine kinase inhibitor (TKI) therapy for patients with chronic myeloid leukemia (CML) in the stable chronic phase. The therapeutic rationale is based on the hypothesis that EPA is metabolized into Δ12-prostaglandin J3 (Δ12-PGJ3), which selectively targets and eliminates BCR-ABL positive leukemia stem cells (LSCs). While standard TKIs effectively manage the bulk of CML cells by inhibiting the BCR-ABL tyrosine kinase, they often fail to eradicate the LSC population, which can lead to disease persistence or relapse. The Milton S. Hershey Medical Center conducted a Phase I/II trial (NCT04006847) to evaluate the safety, tolerability, and efficacy of adding daily oral EPA to a patient's existing TKI regimen (such as imatinib, dasatinib, or nilotinib). The study aimed to achieve deeper molecular responses by reducing residual leukemia stem cells, although the trial was ultimately terminated due to low patient enrollment.
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