Phase 2 Study of 5 Days Azacytidine Priming Prior to Fludarabine, Cytarabine and Granulocyte-Colony Stimulating Factor (G-CSF) Combination for Patients With Relapsed or Refractory AML
试验速览
- 阶段
- 2 期
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- complete response rate
研究概览
简要总结
The purpose of this phase 2 study is to test the efficacy of azacytidine given prior to fludarabine, cytarabine, and G-CSF for the treatment of relapsed or refractory acute myeloid leukemia.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 to 60
- •Patients with a diagnosis of relapse or refractory AML (≥ 20% blast in bone marrow).
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Patients must have preserved organ function as defined below:
- •Creatinine ≤ 1.5 mg/dl
- •Total bilirubin ≤ 1.5x upper limit of the normal
- •Alanine aminotransferase (ALT) ≤ 2x upper limit of the normal
- •Left ventricular ejection fraction (LVEF) ≥ 45%
排除标准
- •Patients with a diagnosis of acute promyelocytic leukemia (AML -M3)
- •Pregnant women
- •Patients previously treated with fludarabine are allowed to participate.
- •Patients with Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Azacytidine plus FLAG
Azacytidine 75 mg/m2 = mg IV in 100 ml Normal Saline (NS) over 30 minutes on days -5 t0 -1
G-CSF 5 mcg/kg subcut on days 0 to + 6
Fludarabine 30mg/m² in 100ml NS IV daily over 30min., on Days +1 to +5
Cytarabine 2gm/m² = 500ml NS IV daily over 4h, on Days +1 to +5 Start 4h after completion of fludarabine infusion.
干预措施: Azacytidine (Drug)
Azacytidine plus FLAG
Azacytidine 75 mg/m2 = mg IV in 100 ml Normal Saline (NS) over 30 minutes on days -5 t0 -1
G-CSF 5 mcg/kg subcut on days 0 to + 6
Fludarabine 30mg/m² in 100ml NS IV daily over 30min., on Days +1 to +5
Cytarabine 2gm/m² = 500ml NS IV daily over 4h, on Days +1 to +5 Start 4h after completion of fludarabine infusion.
干预措施: Fludarabine (Drug)
Azacytidine plus FLAG
Azacytidine 75 mg/m2 = mg IV in 100 ml Normal Saline (NS) over 30 minutes on days -5 t0 -1
G-CSF 5 mcg/kg subcut on days 0 to + 6
Fludarabine 30mg/m² in 100ml NS IV daily over 30min., on Days +1 to +5
Cytarabine 2gm/m² = 500ml NS IV daily over 4h, on Days +1 to +5 Start 4h after completion of fludarabine infusion.
干预措施: Cytarabine (Drug)
Azacytidine plus FLAG
Azacytidine 75 mg/m2 = mg IV in 100 ml Normal Saline (NS) over 30 minutes on days -5 t0 -1
G-CSF 5 mcg/kg subcut on days 0 to + 6
Fludarabine 30mg/m² in 100ml NS IV daily over 30min., on Days +1 to +5
Cytarabine 2gm/m² = 500ml NS IV daily over 4h, on Days +1 to +5 Start 4h after completion of fludarabine infusion.
干预措施: Filgrastim (Drug)
结局指标
主要结局
complete response rate
时间窗: 6 weeks
bone marrow blast \<5% with complete neutrophil (\>1000/ul) and platelets (\>100,000/ul) recovery
次要结局
- leukemia free survival(1-3 years)
- overall survival(1-3 yeears)
- one year leukemia free survival(1 year)
研究者
Ibraheem Motabi
Consultant, Hematology and BMT
King Fahad Medical City