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

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ClinicalTrials.gov Identifier: NCT01999413
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
French Innovative Leukemia Organisation

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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 : November 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 2018


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 Name: Cerubidine

Drug: Cytarabine
AML Study treatment induction phase
Other Name: Aracytine




Primary Outcome Measures :
  1. response to study treatment [ Time Frame: 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 :
  1. Tolerance [ Time Frame: 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

  2. Efficacy on peripheral blasts decrease [ Time Frame: 1 month ]
    Daily quantification of peripheral blasts by flow cytometry during the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy

  3. pharmacokinetics [ Time Frame: 1 month ]
    Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion



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Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999413


Locations
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France
Emmanuel GYAN
Tours, France, 37044
Sponsors and Collaborators
French Innovative Leukemia Organisation
Fresenius Kabi
Investigators
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Principal Investigator: Emmanuel GYAN, MD French Innovative Leukemia Organisation

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: French Innovative Leukemia Organisation
ClinicalTrials.gov Identifier: NCT01999413     History of Changes
Other Study ID Numbers: FAMYLY
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by French Innovative Leukemia Organisation:
AML
high-risk cytogenetics
younger patients
Induction treatment
OMEGAVEN
Additional relevant MeSH terms:
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Cytarabine
Daunorubicin
Leukemia
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors