Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia

This is an interventional treatment trial for Chronic Myeloid Leukemia, Chronic Phase focused on measuring Omega-3 Fatty Acid, Eicosapentaenoic Acid, Tyrosine Kinase Inhibitors, TKI, GoldAID Eicosapentaenoic Acid, Fish Oil Read More

Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Confirmed diagnosis of CML ≥ 18 months from diagnosis.
3. Current concomitant treatment with TKI therapy (Imatinib, Dasatinib, Nilotinib or Bosutinib; excluding Ponatinib). TKI therapy should be stable (same drug and dose) for at least 3 months prior to study enrollment.

4. One of the following confirmed:

   1. BCR-ABL p210 at stable molecular disease (e.g., MMR stable but not CMR)
   2. HR but no MMR.
5. Stable molecular response defined as 2 sequential BCR-ABL p210 levels done in the same lab with less than ½ log reduction of BCR-ABL (BA) 3-6 months apart.
6. ECOG PS of ≤ 3

7. Adequate organ function, as defined by the following:

   ANC ≥ 500 cells/mm3 Platelet count ≥ 50,000 cells/mm3 Serum bilirubin ≤ 1.5 x ULN AST and ALT ≤ 2.5 x ULN Alkaline phosphatase ≤ 2.5 x ULN

8. WOCP as defined as defined as not surgically sterile or not one year post-menopausal, must have a negative result for a serum or urine pregnancy test within 7 days of initial receipt of study drug. Surgically sterile is defined as having had a hysterectomy, tubal ligation, or oophorectomy.
9. WOCP must use a medically accepted method of contraception and must agree to continued use of this method for the duration of the study and for 30 days after last dose of study drug. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD) known to have a failure rate of less than 1% per year, or steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method.
10. Male subjects capable of producing offspring, must use a medically accepted method of birth control and agree to continued use of this method for the duration of the study and for 30 days after last dose of study drug because of the possible effects on spermatogenesis. Acceptable methods of contraception include abstinence, barrier method with spermicide, WOCP partner's use of an IUD known to have a failure rate of less than 1% per year, WOCP partner's use of steroidal contraceptive (oral, implanted or injected) in conjunction with a barrier method, WOCP partner is surgically sterile or 1 year postmenopausal. In addition, male subjects may not donate sperm for the duration of the study and for 30 days after last dose of study drug.

Exclusion Criteria:

1. Has a malignancy or infection requiring active treatment
2. Has a known HIV infection, Hepatitis B , or Hepatitis C infection
3. Has a known symptomatic congestive heart failure (CHF), unstable angina or cardiac arrhythmia
4. Is using Aspirin or NSAID or COX-I
5. Is known to be non-compliant to medications.
6. Has, in the opinion of the physician investigator, an uncontrolled medical or psychiatric disorder.
7. Has active central nervous system (CNS) leukemia.
8. Is preceding allogeneic stem HSCT.
9. Has a known T 315 I mutation.
10. Is taking FISH oil at EPA dose > 500 mg