SNPMiner Trials by Shray Alag

SNPMiner SNPMiner Trials (Home Page)

Report for Clinical Trial NCT04006847

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Effect of Omega-3 Fatty Acid, Eicosapentaenoic Acid, and Its Metabolites in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia in Stable Chronic Phase

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.

NCT04006847 Chronic Myeloid Leukemia, Chronic Phase
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

2 Interventions

Name: Eicosapentaenoic Acid

Description: Eicosapentaenoic Acid once per day orally
Type: Drug
Group Labels: 1

Eicosapentaenoic Acid (EPA)

Name: Tyrosine kinase inhibitor

Description: Tyrosine kinase inhibitor to be administered at subjects' pre-study dose
Type: Drug
Group Labels: 1

Eicosapentaenoic Acid (EPA)

Primary Outcomes

Description: Recommended Phase II dose of EPA will be established by using a standard 3 + 3 statistical design to determine the MTD as assessed by DLTs when administered orally in combination with a TKI in subjects with CML in stable chronic phase. Toxicity will be evaluated using the NCI Common Toxicity Criteria (CTC) version 5.0.

Measure: Phase I - Recommended Phase II dose of EPA

Time: 1 month

Description: BCR-ABL transcript levels will be assessed every 3 months post initiation of Eicosapentaenoic Acid to assess Anti-CML response.

Measure: Phase II - Anti-CML response to recommended Phase II dose Eicosapentaenoic Acid

Time: 1 year

Secondary Outcomes

Description: Using the NCI CTC Version 5.0, AEs will be assessed from the time of initiation of investigational medication

Measure: Number of subjects who experience treatment related Adverse Events (AEs)

Time: 2 years

Description: Using the NCI CTC Version 5.0, the highest grade of all treatment related AEs collected will be used to determine severity

Measure: Severity of AEs experienced by study subjects

Time: 2 years

Description: Proportion of protocol prescribed doses taken by subjects

Measure: Study subject compliance with investigational regimen

Time: 2 years

Description: Log reduction from stable molecular response with bcr-abl PCR at MR 3 or more to bcr-abl to major molecular response (MR 4.5) or complete molecular response

Measure: Molecular responses of CML

Time: 1 year

Description: Apoptosis will be analyzed by in vitro correlative studies using subject's plasma with effect on known leukemia cell line with CML leukemic stem cells. EPA metabolite will be examined by flow cytometry using Annexin V staining and adding serum from treated study subject to murine CML cells grown in vitro culture. The evaluation will be done at baseline, Month 1, and every 3 months up to year 2

Measure: Induction of apoptosis in CML leukemia stem cell by formation of Δ12-PGJ3 and other metabolites

Time: 2 years

Purpose: Treatment

Sequential Assignment

There is one SNP


1 T315I

- Known T315I mutation. --- T315I ---

HPO Nodes