Acute Myeloid Leukemia (AML)
Conditions
Keywords
AML, high-risk cytogenetics, younger patients, Induction treatment, OMEGAVEN
Brief summary
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.
Detailed description
Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.
Interventions
DRUGOMEGAVEN
AML Study treatment induction phase
DRUGDaunorubicin
AML Study treatment induction phase
DRUGCytarabine
AML Study treatment induction phase
Sponsors
Fresenius Kabi
French Innovative Leukemia Organisation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 61 Years
Healthy volunteers
No
Inclusion criteria
* Patient between 18 and 60 years old (less than 61 years old) * With newly diagnosed with AML according to WHO classification: * With 20% or more blasts in the bone marrow * Patients with history of tumors other than myeloproliferative disorders or myelodysplastic syndromes, having received chemotherapy and/or radiotherapy without previous history of myelodysplastic syndromes are eligible for the present study * High-risk cytogenetics defined as one the following abnormalities : 5/5q-, 7/7q-, t(6,9), 11q23 abnormality excluding t(9;11), 3q abnormality,complex karyotype (\>3 abnormalites) * Left ventricular ejection fraction (LVEF) \> 50% on echocardiography or multigated acquisition (MUGA) scan or similar radionuclide angiographic scan. * Adequate liver function (all of the following) except if secondary to the leukemia: Total bilirubin below 1.5 x upper limit of normal (ULN), AST and ALT below 2.5 x ULN , gamma-GT below 2.5 x ULN, * Adequate kidney function (all of the following): Serum creatinine below 1.5 x ULN, Creatinine clearance above 50 mL/min (Cockroft and Gault formula) * ECOG performance status \< or = 2. * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. * The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient. * Affiliated to the French Social Security (Health Insurance).
Exclusion criteria
* Previous allogeneic stem cell transplantation. * Pre-existing aplastic anemia * Presence of favourable cytogenetics with t(8;21), t(15;17), or inv(16) * Previous history of MDS or myeloproliferative neoplasm * Uncontrolled active infection. * History of arrythmia. * Cardiac toxicity induced by another anthracycline administration * Maximum cumulative dose reached for any anthracyclin * Allergy to cytarabine, daunorubicin, fish or egg proteins10. Significant neurologic (grade \> 2) or psychiatric disorder, dementia or seizures. * Clinical symptoms suggesting active central nervous system leukemia. * Degenerative or toxic encephalopathy * Severe complications of leukemia such as:Uncontrolled bleeding, Pneumonia with hypoxia or shock * Prior total body irradiation \> 10 Gy. * Known active HIV, Hepatitis B or C infection * Pregnancy or breastfeeding * Concomitant anti-amarile vaccination (yellow fever) * Concurrent treatment with any other anti-cancer therapy except Hydroxyurea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response to study treatment | 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance | 4 months | 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 |
| Efficacy on peripheral blasts decrease | 1 month | Daily quantification of peripheral blasts by flow cytometry during the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy |
| pharmacokinetics | 1 month | Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion |
Countries
France
Outcome results
None listed