Clinical trial · Interventional
Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients
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
NCT01999413CI-TRIAL-00032700FAMYLYcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| OMEGAVEN | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OMEGAVEN - Daunorubicin - Cytarabine
- 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
- interventionNames
- Drug: OMEGAVEN
- Drug: Daunorubicin
- Drug: Cytarabine
Primary outcomes (1)
- measure
- response to study treatment
- timeFrame
- 1 month
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 61 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDGyan 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
- DERIVEDPicou 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
- DERIVEDGyan 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