Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French Innovative Leukemia Organisation
• Collaborator: Fresenius Kabi
• Treatments: Cytarabine; Daunorubicin

Criteria

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