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

Sponsor

French Innovative Leukemia Organisation (Other)

Overall Status

Completed

CT.gov ID

NCT01999413

Collaborator

Fresenius Kabi (Industry)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)	Drug: OMEGAVEN Drug: Daunorubicin Drug: Cytarabine	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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 With High-risk Cytogenetics

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OMEGAVEN - Daunorubicin - Cytarabine 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	Drug: OMEGAVEN AML Study treatment induction phase Drug: Daunorubicin AML Study treatment induction phase Other Names: Cerubidine Drug: Cytarabine AML Study treatment induction phase Other Names: Aracytine

Arm

Intervention/Treatment

Experimental: OMEGAVEN - Daunorubicin - Cytarabine

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

Drug: OMEGAVEN

AML Study treatment induction phase

Drug: Daunorubicin

AML Study treatment induction phase

Other Names:

Cerubidine

Drug: Cytarabine

AML Study treatment induction phase

Other Names:

Aracytine

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 61 Years

Sexes Eligible for Study:

All

Accepts 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