An Open Label Phase II Clinical Study to Evaluate the Safety and Pharmacokinetics of Oral Encochleated Amphotericin B (CAMB/MAT2203) for Antifungal Prophylaxis in Patients Undergoing Induction Chemotherapy for Acute Myelogenous (AML) and Lymphoblastic Leukaemia (ALL)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
A Non-randomized, prospective , multicenter, open uncontrolled study in patients with acute myelogenous (AML) or lymphoblastic leukaemia (ALL)
详细描述
This is an open label phase II clinical study to evaluate the safety and pharmacokinetics of oral encochleated Amphotericin B (CAMB/MAT2203) for prevention of invasive fungal infections in approximately 30 patients undergoing induction therapy for AML/ALL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Newly diagnosed AML/ALL receiving chemotherapy inducing neutropenia < 500 cells/mm3
- •Able to have all screening tests done to allow for study drug administration no later than 5 days after start of chemotherapy
- •Sign informed consent
- •≥ 18 years of age
排除标准
- •Known hypersensitivity to amphotericin B, specifically anaphylactic reaction
- •Fungal induced fever (≥ 38°C)
- •Proven, possible or probably invasive fungal infection in previous 12 months
- •Serum galactomannan index (GMI)≥ 0.5 at screening
- •Pulmonary infiltrates at screening
- •Current treatment with amphotericin B
- •Sever comorbidity other than underlying haematological disease
- •Prolongation of corrected QT interval
- •History of convulsion
- •Pregnant or breastfeeding
- •Females of childbearing potential who do not practice sexual abstinence or who do not agree to use appropriate contraceptive methods
- •Presence of hepatic disease
- •Total bilirubin > 3 x upper limit of normal
- •Age-adjusted creatinine clearance < 30 mL/minute
- •Participating in any other clinical study
研究组 & 干预措施
CAMB 200 mg
200 mg CAMB (MAT2203) Oral Amphotericin B
干预措施: Oral Encochleated Amphotericin B (CAMB) (Drug)
CAMB 400 mg
400 mg CAMB (MAT2203) Oral Amphotericin B
干预措施: Oral Encochleated Amphotericin B (CAMB) (Drug)
CAMB 800mg
800 mg CAMB (MAT2203) Oral Amphotericin B
干预措施: Oral Encochleated Amphotericin B (CAMB) (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: 35 days
Safety assessments include laboratory tests, vital signs, physical exam and ECG
次要结局
- Efficacy analysis for time to clinical symptoms of fungal infection(35 days)
- Population pharmacokinetic (PK) analysis(35 days)