FLAG-IDA Chemotherapy Induction Follow by Intensive Chemotherapy Postremission +/- Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 16
- 主要终点
- Evaluation of efficacy of study treatment: complete remission rate, remission duration and global survival
研究概览
简要总结
Association group of therapeutic specialities authorized in a remission induction treatment(FLAG-IDA: fludarabine, cytarabine, G-CSF (lenograstim) and idarubicin) and an intensive postremission treatment with authorized therapeutic association specialities and with/without Autologous Hemopoietic Stem Cell Transplantation or Bone Marrow Transplantation in Patients With High Risk Myelodysplastic Syndromes or Secondary Acute Myeloblastic Leukemia.
详细描述
To reach the first remission, the patients receive one cycle of FLAG-IDA combination, that include: Fludarabine 30 mg/m 2 /d Days 1 to 4 in IV perfusion during 30 minutes; Cytarabine 2 g/m 2/d, days 1 to 4 in IV perfusion during 4 hours glycosylate G-CSF 300 µg/m 2/d, days -1 to 5 SC; lenograstim 263 µg/d f, days 11 until absolute neutrophil count >1x10 9 /L SC; Idarubicin 10 mg/m2/d, days 1 to 3 IV bolus (15 minutes)
Patients who don't reach complete remission (CR) are considered as a failure and must go out of study.
The participating centres should decide if the patients under 35 years in CR and with unrelated donor, are excluded to be treated with allogenic transplantation or they continue in the study.
The patients who reach CR will receive one consolidation cycle with IDA-ARAC + G-CSF combination:
Idarubicin 10 mg/m2/d, days 1 to 3 IV bolus (15 minutes); Cytarabine 200 mg/m 2/d days 1 to 5 IV in 24 hours continuous perfusion; glycosylate G-CSF(lenograstim) 263 µg, days 12 until absolute neutrophil count >1x10 9 /L SC
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
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 75 years
- •Diagnosis of Myelodysplastic Syndrome in order to FAB criteria, excluding patients with chronic myeloid leukemia.
- •IPI > 1 (High risk or Intermedia risk-2) and/or IPE equal or > 3 (High risk o Intermedia risk) or secondary acute myeloid leukemia.
- •Resolved toxicity for previous treatments received to Myelodysplastic Syndrome .
- •Myelodysplastic Syndrome de novo.
排除标准
- •Associated neoplasia.
- •Chronic disease that can limit the patient follow up protocol (cardiovascular disease, active infection uncontrolled, etc.).
- •Age < 55 years with related donor HLA compatible.
- •Use an investigational drug in the 30 previous days.
- •Previous treatment with chemotherapy agents.
- •Simultaneous treatment during the study with other drugs not allowed in the protocol.
- •Bilirubin > 2 mg/dL and GPT >2 times the normal value.
- •Creatinine > 2 mg/dL.
- •Hypersensibility to agents used in the protocol.
- •Secondary MDS to chemo-radiotherapy .
- •HIV positive.
- •Chronic myeloblastic leukemia
结局指标
主要结局
Evaluation of efficacy of study treatment: complete remission rate, remission duration and global survival
时间窗: 2 years
次要结局
- Evaluation of neutropenia and thrombocytopenia duration post-induction chemotherapy(3 months)
- Determinate the percentage of patients that reach the transplantation(3 months)
- Determinate the toxicity of induction regimen and the chemotherapy postremission(1 year)