Trial Outcomes & Findings for Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (NCT NCT04006847)
NCT ID: NCT04006847
Last Updated: 2022-07-01
Results Overview
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.
TERMINATED
PHASE1/PHASE2
1 participants
the time of initiation of the study medication to 30 days after last dose of study medication
2022-07-01
Participant Flow
One subject was consented but withdrew from participation.
Participant milestones
| Measure |
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
Eicosapentaenoic Acid: Eicosapentaenoic Acid once per day orally
Tyrosine kinase inhibitor: Tyrosine kinase inhibitor to be administered at subjects' pre-study dose
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
Eicosapentaenoic Acid: Eicosapentaenoic Acid once per day orally
Tyrosine kinase inhibitor: Tyrosine kinase inhibitor to be administered at subjects' pre-study dose
|
|---|---|
|
Overall Study
Product issue
|
1
|
Baseline Characteristics
Omega -3 Fatty Acid in Combination With Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Eicosapentaenoic Acid (EPA)
n=1 Participants
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
Eicosapentaenoic Acid: Eicosapentaenoic Acid once per day orally
Tyrosine kinase inhibitor: Tyrosine kinase inhibitor to be administered at subjects' pre-study dose
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: the time of initiation of the study medication to 30 days after last dose of study medicationPopulation: data were not collected
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: data were not collected
BCR-ABL transcript levels will be assessed every 3 months post initiation of Eicosapentaenoic Acid to assess Anti-CML response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: data were not collected
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: data were not collected
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
Outcome measures
Outcome data not reported
Adverse Events
Eicosapentaenoic Acid (EPA)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place