SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT04006847

Developed by Shray Alag, 2019.
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 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

Eicosapentaenoic Acid (EPA)

Name: Tyrosine kinase inhibitor

Description: Tyrosine kinase inhibitor to be administered at subjects' pre-study dose

Type: Drug

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: Analyzed by in vitro correlative studies using subject's plasma with effect on known leukemia cell line with CML leukemic stem cells.

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

SNPs


1 T315I

Known T315I mutation. --- T315I ---



HPO Nodes


HPO:
Chronic myelogenous leukemia
Genes 5
MPL BCR JAK2 KIT THPO
Leukemia
Genes 125
MPL RNASEH2B KRAS NPM1 TET2 MYD88 TSR2 RPL26 RPL27 TREX1 EFL1 PIGL SCN11A FLT3 PMS2 RPL35A EVC2 ABL1 CEBPA RARA NRAS WAS WIPF1 ATRX SH2B3 PDGFRA RB1 RNASEH2A PDGFRB CALR ARHGAP26 SH3GL1 RPS7 RPS10 NUMA1 GATA1 GATA2 RPS15A APC NSD1 ETV6 TCIRG1 DNAJC21 EVC SRP54 RPS17 NBN RPS19 SAMHD1 MSH2 RPS24 NUP214 RPS26 RPS27 RPS28 RPS29 MLLT10 RUNX1 XRCC4 CBFB CBL BCR ADAR TRIP13 ADA2 NSUN2 CREBBP PICALM GFI1 F13A1 F13B FANCA FANCC BLM FANCD2 FANCE NUTM1 JAK2 IFIH1 TYROBP MSH6 FANCG LIG4 PTPN11 SAMD9L THPO NF1 STS PIGA BRCA2 DYNC2LI1 PIK3CA SBDS GLI1 PIK3R1 BRD4 SETBP1 RNASEH2C LPP BUB1 BUB1B SCN9A SCN10A TREM2 MLF1 MLH1 ELANE DKC1 ATM HAX1 RPL35 GNB1 BUB3 CEP57 TAL1 KIT TAL2 RPL5 EP300 TP53 RPL11 KIF11 RPL15 DNMT3A RPL18
Myeloid leukemia
Genes 12
GATA2 F13A1 CBL ARHGAP26 F13B KRAS PTPN11 SAMD9L KIT SETBP1 NF1 NRAS