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

French Innovative Leukemia Organisation

Status and phase: Completed; Phase 2

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Drug: OMEGAVEN; Drug: Cytarabine; Drug: Daunorubicin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01999413

FAMYLY

Details and patient eligibility

About

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.

Full description

Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.

Enrollment: 30 patients

Sex: All

Ages: 18 to 61 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

OMEGAVEN - Daunorubicin - Cytarabine

Experimental group

Description:

If WBC ≥ 30 G/L, chemotherapy the induction cycle : * Daunorubicin 60 mg/m²/day IV on D1, D2, and D3 * Cytarabine 200 mg/m²/day D1 to D7 * OMEGAVEN® 2 ml/kg D1 to D9, If WBC ≤ 30 G/L, OMEGAVEN during 48 hours Induction cycle : OMEGAVEN® 2 ml/kg D-2 to D7 Daunorubicin 60 mg/m²/day IV on D1, D2, and D3 - Cytarabine 200 mg/m²/day IV D1 to D7 bone marrow aspirate at D15: If BM blasts are \> 5% or if second induction course : * Daunorubicin 35 mg/m²/day IV D17 and D18 * OMEGAVEN® 2 ml/kg * Cytarabine 1000 mg/m²/12h IV on D17, D18, and D19 For all patients: G-CSF 5 µg/kg/day subcutaneously from D21 to hematopoietic recovery (PMN \> 1 G/L or \> 0.5 G/L during 3 days). Consolidation will be administered at investigator's discretion

Treatment:

Drug: Daunorubicin

Drug: Cytarabine

Drug: OMEGAVEN