Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients
Phase 2
Completed
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- Registration Number
- NCT01999413
- Lead Sponsor
- 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.
- Detailed Description
Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OMEGAVEN - Daunorubicin - Cytarabine 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 OMEGAVEN - Daunorubicin - Cytarabine Daunorubicin 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 OMEGAVEN - Daunorubicin - Cytarabine OMEGAVEN 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
- Primary Outcome Measures
Name Time Method response to study treatment 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
Name Time Method Tolerance 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
Efficacy on peripheral blasts decrease 1 month Daily quantification of peripheral blasts by flow cytometry during the adjunction of a Fish oil emulsion to daunorubicin and cytarabine chemotherapy
pharmacokinetics 1 month Measure of plasma concentration of daunorubicin and cytarabine administered together with a fish oil emulsion
Trial Locations
- Locations (1)
Emmanuel GYAN
🇫🇷Tours, France