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

Primary Purpose

Acute Myeloid Leukemia (AML)

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
OMEGAVEN
Daunorubicin
Cytarabine
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring AML, high-risk cytogenetics, younger patients, Induction treatment, OMEGAVEN

Eligibility Criteria

18 Years - 61 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Emmanuel GYAN

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OMEGAVEN - Daunorubicin - Cytarabine

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerance
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
Daily quantification of peripheral blasts by flow cytometry during the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy
pharmacokinetics
Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion

Full Information

First Posted
November 15, 2013
Last Updated
April 26, 2018
Sponsor
French Innovative Leukemia Organisation
Collaborators
Fresenius Kabi
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1. Study Identification

Unique Protocol Identification Number
NCT01999413
Brief Title
Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients
Acronym
FAMYLY
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 Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Innovative Leukemia Organisation
Collaborators
Fresenius Kabi

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML)
Keywords
AML, high-risk cytogenetics, younger patients, Induction treatment, OMEGAVEN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OMEGAVEN - Daunorubicin - Cytarabine
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
OMEGAVEN
Intervention Description
AML Study treatment induction phase
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Other Intervention Name(s)
Cerubidine
Intervention Description
AML Study treatment induction phase
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Aracytine
Intervention Description
AML Study treatment induction phase
Primary Outcome Measure Information:
Title
response to study treatment
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Tolerance
Description
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
Time Frame
4 months
Title
Efficacy on peripheral blasts decrease
Description
Daily quantification of peripheral blasts by flow cytometry during the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy
Time Frame
1 month
Title
pharmacokinetics
Description
Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel GYAN, MD
Organizational Affiliation
French Innovative Leukemia Organisation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emmanuel GYAN
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35697729
Citation
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.
Results Reference
derived
PubMed Identifier
30142422
Citation
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.
Results Reference
derived
PubMed Identifier
29505137
Citation
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.
Results Reference
derived
Links:
URL
http://www.filo-leucemie.org
Description
FILO site

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

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