Efficacy and Safety of Ambulatory Low-dose Venetoclax and Azacitidne as First Line Therapy in Newly Diagnosed AML: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility will be address by obtaining the proportion of patients who need hospitalization
研究概览
简要总结
Venetoclax plus azacitidine are effective in treating newly diagnosed AML in patients who cannot recieve intensive chemotherapy. However there is no clinical data rewarding the efficacy and safety of low-dose venetoclax and azacitidine as first-line therapy.
详细描述
Venetoclax plus azacitidine are effective in treating newly diagnosed AML in patients who cannot recieve intensive chemotherapy. However there is no clinical data rewarding the efficacy and safety of low-dose venetoclax and azacitidine as first-line therapy. This phase 2 clinical trial will explore the efficacy and safety of low-dose venetoclax (100mg /day/21 days) and a fixed dose of azacitidine (75mg/m2, maximun dose 100mg, SC for seven consecutive days) for a maximun of two cycles.
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
盲法说明
This is an Open label study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Both genders
- •Diagnosis of non-m3 AML by the WHO 2016 diagnostic criteria
- •Patients eligible and not eligible for transplant
- •AML secondary to treatment or associated to myelodisplasia
排除标准
- •AML with PML/RAR-alfa translocation t(15;17)
- •Central nervous system involvement
- •Poor functional status (ECOG>2)
- •Organic dysfunction (Marshall score ≥2)
- •Active infection
- •Use of other CYP3A4 inhibitors
- •GFR <30 ml/min/1.72m2
研究组 & 干预措施
Low-dose Ventoclax and oral itraconazol plus subcutaneous Azacitdine
Patients will recieve Low-dose Venetoclax at a dose of 100mg/day por 21 days, oral itraconazol 100mg every 12 hours, and subcutaneous Azacitidine 75mg/m2 (maximun dose 100mg) daily for seven days. Each cycle duration is 21 days and patients will recieve a maximun of two cycles.
干预措施: Venetoclax 100 MG (Drug)
Low-dose Ventoclax and oral itraconazol plus subcutaneous Azacitdine
Patients will recieve Low-dose Venetoclax at a dose of 100mg/day por 21 days, oral itraconazol 100mg every 12 hours, and subcutaneous Azacitidine 75mg/m2 (maximun dose 100mg) daily for seven days. Each cycle duration is 21 days and patients will recieve a maximun of two cycles.
干预措施: Itraconazole capsule (Drug)
Low-dose Ventoclax and oral itraconazol plus subcutaneous Azacitdine
Patients will recieve Low-dose Venetoclax at a dose of 100mg/day por 21 days, oral itraconazol 100mg every 12 hours, and subcutaneous Azacitidine 75mg/m2 (maximun dose 100mg) daily for seven days. Each cycle duration is 21 days and patients will recieve a maximun of two cycles.
干预措施: Azacitidine Injection (Drug)
结局指标
主要结局
Feasibility will be address by obtaining the proportion of patients who need hospitalization
时间窗: 1 month
If therapy is feasible \>50% of patients will recieve their first cycle of treatment without hospitalization
Safety will be defined by the number of patients deceased before 14 days of initiating treatment
时间窗: 2 weeks
If therapy is safe then \<10% of patients will die in the first 14 days of treatment
Safety will be defined by the number of patients deceased before 30 days of initiating treatment
时间窗: 1 month
If therapy is safe then \<20% of patients will die in the first 30 days of treatment
次要结局
- Efficacy will be achieved if the overall response rate is similar to standard of care (7+3)(2 months)
研究者
David Gomez Almaguer
Head of Hematology Service
Hospital Universitario Dr. Jose E. Gonzalez