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PSCI-17-085 Effect of Omega-3 Fatty Acid (EPA) and its Metabolites in Combination with Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia (CML) in Stable Chronic Phase

The purpose of this Phase I/II study is to evaluate the safety and efficacy of the combination of tyrosine kinase inhibitors (TKIs) and an omega-3 fatty acid (like fish oil) in patients with Chronic Myeloid Leukemia (CML).
Seema Naik at
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Confirmed diagnosis of CML ≥ 18 months from diagnosis
Current concomitant treatment with TKI therapy (Imatinib, Dasatinib, Nilotinib or Bosutinib; excluding Ponatinib)
BCR-ABL PCR at stable molecular disease (e.g. MMR stable but not CMR) or b. Hematologic remission (HR) but no MMR
Stable molecular response defined as 2 sequential BCR-ABL levels done in the same lab with less than ½ log reduction of BCR-ABL (BA)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score more than or equal to 3
Exclusion Criteria:
Current malignancy requiring active treatment
Active infection requiring antibiotic treatment
Known HIV, Hepatitis B, or Hepatitis C infection
Known symptomatic congestive heart failure (CHF), unstable angina or cardiac arrhythmia
Current concomitant use of NSAIDs (including Aspirin) or COX-1; a washout period of 4 weeks prior to enrollment is permitted
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Hershey, PA