NCT07069933尚未招募2 期
"Repurposing Itraconazole as an Adjuvant Therapy in Treatment of Patients With Acute Myeloid Leukemia: Is it a Hopeful Avenue for Enhancing Treatment Options?"
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of blasts in bone marrow at d21 after induction
研究概览
简要总结
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of Itraconazole as an adjuvant therapy in treatment of patients with acute myeloid Leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Acute Myeloid leukemia, and aged 18 years or older
- •Patients whose ECOG performance status ranged from 0-2 and are fit for all treatments protocols
排除标准
- •Patients with any other types of malignancies rather than Leukemia and patients.
- •Patients with history alcohol intake, acute or chronic.
- •Patients with documented hypersensitivity or allergy to Itraconazole.
- •Patients suffer from chronic heart failure
- •Patients present with severe dehydration.
- •Patients with severe kidney dysfunction
研究组 & 干预措施
Control arm
Other
Standard Care
干预措施: Chemotherapy (Drug)
Interventional arm
Active Comparator
Standard Care plus itraconazole
干预措施: Standard care +itraconazole 200mg (Drug)
结局指标
主要结局
Percentage of blasts in bone marrow at d21 after induction
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
Noha Mansour
Lecturer of Clinical Pharmacy and Pharmacy Practice
Mansoura University
研究点 (1)
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