Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia
Status:
Terminated
Trial end date:
2021-05-21
Target enrollment:
Participant gender:
Summary
This is a Phase I/II single site, open label clinical trial. The purpose of the Phase I
portion is to determine the safety, tolerability, and recommended Phase II dose of
Eicosapentaenoic Acid (EPA) when given daily in combination with a Tyrosine Kinase Inhibitor
(TKI) in subjects with Chronic Myeloid Leukemia (CML) in chronic stable phase. The
recommended Phase II dose will be the maximum tolerated dose (MTD) of EPA as determined by
the evaluation of dose-limiting toxicities (DLTs). The Phase II portion will subsequently
examine the Anti-CML effects of EPA when administered with a TKI at the recommended Phase II
dose. This efficacy objective will be done by evaluating BCR-ABL p210 quantitative PCR blood
levels every 3 months to 1 year.