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Acute Myeloid Leukemia (AML)Phase 2FAMYLYNCT01999413

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

A Phase 2 study testing OMEGAVEN, Daunorubicin and Cytarabine in people with Acute Myeloid Leukemia (AML), run by French Innovative Leukemia Organisation at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 61 years
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
OMEGAVEN, Daunorubicin and Cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
Nov 2013to Apr 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 61 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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 locations and contacts

1 site in 1 country.

France1 site

  • Emmanuel GYAN

    Tours, 37044

Other trials in France

About this study

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

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.

Read the detailed description

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

Being tested
OMEGAVEN, Daunorubicin, Cytarabine
Keywords
AML, high-risk cytogenetics, younger patients, Induction treatment, OMEGAVEN
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMEGAVENDrug

    AML Study treatment induction phase

  • DaunorubicinDrug

    Also called Cerubidine

    AML Study treatment induction phase

  • CytarabineDrug

    Also called Aracytine

    AML Study treatment induction phase

Study groups in NCT01999413
Study groupRoleWhat they receive
OMEGAVEN - Daunorubicin - CytarabineExperimentalIf 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
Receives: Drug: OMEGAVEN; Drug: Daunorubicin; Drug: Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 month

Secondary outcomes (3)

  1. 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

    Measured: 4 months

  2. 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

    Measured: 1 month

  3. pharmacokinetics

    Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionMar 2016
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01999413
Sponsor's protocol ID
FAMYLY
Acronym
FAMYLY
Status last verified
Apr 2018
First submitted
15 Nov 2013
Last updated
27 Apr 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35697729

  • 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.

    PubMed 30142422

  • 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.

    PubMed 29505137

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OMEGAVEN, Daunorubicin and Cytarabine in people with Acute Myeloid Leukemia (AML), run by French Innovative Leukemia Organisation at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

response to study treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01999413, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.

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