Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04006847|
Recruitment Status : Not yet recruiting
First Posted : July 5, 2019
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia, Chronic Phase||Drug: Eicosapentaenoic Acid Drug: Tyrosine kinase inhibitor||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Phase I/II, open-label, single site study using a standard 3 + 3 statistical design to determine the MTD and the recommended Phase 2 dose for oral EPA when administered to subjects receiving on a TKI pre-study.|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||August 1, 2021|
|Estimated Study Completion Date :||August 1, 2023|
Experimental: Eicosapentaenoic Acid (EPA)
Phase I: TKI with escalating/de-escalating doses of EPA to determine MTD.
Phase I dose levels: Dose Level 1 = EPA 1500 mg orally once per day; Dose Level 2 = EPA 2000 mg orally once per day; Dose Level 3 = EPA 3000 mg orally once per day; Dose Level -1 = EPA 1000 mg orally once per day; Dose Level -2 = EPA 500 mg orally once per day.
Phase II: TKI administered in combination with the recommended Phase II dose of EPA
Drug: Eicosapentaenoic Acid
Eicosapentaenoic Acid once per day orally
Other Name: Omega-3 fatty acid
Drug: Tyrosine kinase inhibitor
Tyrosine kinase inhibitor to be administered at subjects' pre-study dose
- Phase I - Recommended Phase II dose of EPA [ Time Frame: 1 month ]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.
- Phase II - Anti-CML response to recommended Phase II dose Eicosapentaenoic Acid [ Time Frame: 1 year ]BCR-ABL transcript levels will be assessed every 3 months post initiation of Eicosapentaenoic Acid to assess Anti-CML response.
- Number of subjects who experience treatment related Adverse Events (AEs) [ Time Frame: 2 years ]Using the NCI CTC Version 5.0, AEs will be assessed from the time of initiation of investigational medication
- Severity of AEs experienced by study subjects [ Time Frame: 2 years ]Using the NCI CTC Version 5.0, the highest grade of all treatment related AEs collected will be used to determine severity
- Study subject compliance with investigational regimen [ Time Frame: 2 years ]Proportion of protocol prescribed doses taken by subjects
- Molecular responses of CML [ Time Frame: 1 year ]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
- Induction of apoptosis in CML leukemia stem cell by formation of Δ12-PGJ3 and other metabolites [ Time Frame: 2 years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006847
|Contact: Seema Naik, MD||(717) firstname.lastname@example.org|
|Contact: Clinical Research Nurse Hematological Malignancies||(717) 531-6585|
|Principal Investigator:||Seema Naik, MD||Penn State Cancer Institute|