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

NCT01999413 | Completed Phase 2 DMC

• 1 other identifier: FAMYLY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

AML; high-risk cytogenetics; younger patients; Induction treatment; OMEGAVEN

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Secondary Outcomes (3)

• Tolerance

  4 months

• Efficacy on peripheral blasts decrease

  1 month

• pharmacokinetics

  1 month

Study Arms (1)

OMEGAVEN - Daunorubicin - Cytarabine

EXPERIMENTAL

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; Drug: Daunorubicin; Drug: Cytarabine

Interventions

OMEGAVEN DRUG

AML Study treatment induction phase

OMEGAVEN - Daunorubicin - Cytarabine

Daunorubicin DRUG

AML Study treatment induction phase

Also known as: Cerubidine

OMEGAVEN - Daunorubicin - Cytarabine

Cytarabine DRUG

AML Study treatment induction phase

Also known as: Aracytine

OMEGAVEN - Daunorubicin - Cytarabine

Eligibility Criteria

• Age: 18 Years - 61 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead
• Fresenius Kabi: collaborator

Study Sites (1)

Emmanuel GYAN

Tours, 37044, France

Location

Related Publications (3)

• Gyan E, Pigneux A, Hunault M, Peterlin P, Carre M, Bay JO, Bonmati C, Gallego-Hernanz MP, Lioure B, Bertrand P, Vallet N, Ternant D, Darrouzain F, Picou F, Bene MC, Recher C, Herault O. Adjunction of a fish oil emulsion to cytarabine and daunorubicin induction chemotherapy in high-risk AML. Sci Rep. 2022 Jun 13;12(1):9748. doi: 10.1038/s41598-022-13626-y.

  PMID: 35697729 DERIVED

• Picou F, Debeissat C, Bourgeais J, Gallay N, Ferrie E, Foucault A, Ravalet N, Maciejewski A, Vallet N, Ducrocq E, Haddaoui L, Domenech J, Herault O, Gyan E. n-3 Polyunsaturated fatty acids induce acute myeloid leukemia cell death associated with mitochondrial glycolytic switch and Nrf2 pathway activation. Pharmacol Res. 2018 Oct;136:45-55. doi: 10.1016/j.phrs.2018.08.015. Epub 2018 Aug 22.

  PMID: 30142422 DERIVED

• Gyan E, Raynard B, Durand JP, Lacau Saint Guily J, Gouy S, Movschin ML, Khemissa F, Flori N, Oziel-Taieb S, Bannier Braticevic C, Zeanandin G, Hebert C, Savinelli F, Goldwasser F, Hebuterne X; NutriCancer2012 Investigator Group. Malnutrition in Patients With Cancer: Comparison of Perceptions by Patients, Relatives, and Physicians-Results of the NutriCancer2012 Study. JPEN J Parenter Enteral Nutr. 2018 Jan;42(1):255-260. doi: 10.1177/0148607116688881. Epub 2017 Dec 11.

  PMID: 29505137 DERIVED

Related Links

• FILO site

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

fish oil triglycerides; Daunorubicin; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Emmanuel GYAN, MD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: December 3, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2018
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)