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

Acute Myeloid Leukemia (AML) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999413
• Other study ID #: FAMYLY
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2013
• Last updated: April 26, 2018
• Start date: November 2013
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• OMEGAVEN
AML Study treatment induction phase
• Daunorubicin
AML Study treatment induction phase
• Cytarabine
AML Study treatment induction phase

Locations

Country	Name	City	State
France	Emmanuel GYAN	Tours

Sponsors (2)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation	Fresenius Kabi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	4 months
Secondary	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	1 month
Secondary	pharmacokinetics	Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion	1 month

External Links

•   FILO site