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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- response to study treatment
研究概览
简要总结
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.
详细描述
Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of Younger patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 =
- •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).
排除标准
- •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 proteins
- •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
研究组 & 干预措施
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
干预措施: OMEGAVEN (Drug)
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
干预措施: Daunorubicin (Drug)
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
干预措施: Cytarabine (Drug)
结局指标
主要结局
response to study treatment
时间窗: 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
次要结局
- Tolerance(4 months)
- Efficacy on peripheral blasts decrease(1 month)
- pharmacokinetics(1 month)