Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients (under 61 years) with high-risk cytogenetics.
Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
AML Study treatment induction phase
AML Study treatment induction phase
AML Study treatment induction phase
Emmanuel GYAN
Tours, France
response to study treatment
Number of patients incomplete response rate after the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy for the induction of untreated AML
Time frame: 1 month
Tolerance
Number of patients with side effects during and after the admistration of a Fish oil emulsion with daunorubicin and cytarabine chemotherapy for the induction of untreated AML
Time frame: 4 months
Efficacy on peripheral blasts decrease
Daily quantification of peripheral blasts by flow cytometry during the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy
Time frame: 1 month
pharmacokinetics
Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion
Time frame: 1 month
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