A Phase II Open-label Randomized Study of Dietary Supplement With Epigallocatechin Gallate (EGCG) to Improve Cardiac Dysfunction in Patients With AL Amyloidosis Who do Not Require Chemotherapy (EpiCardiAL)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Cardiac response
研究概览
简要总结
In a proportion of patients with AL amyloidosis there is no improvement of cardiac function despite hematologic response to treatment. The aim of the study is to assess whether treatment with EGCG increases the rate of cardiac response in patients with AL amyloidosis who completed chemotherapy.
详细描述
This will be a phase II open-label randomized trial. Patients with AL amyloidosis and cardiac involvement who have achieved at least partial hematologic response after chemotherapy will be randomized to receive standard supportive therapy (SST) or SST plus Epigallocatechin gallate (EGCG). After giving written informed consent, the patients will be evaluated for eligibility. Briefly, the subjects with a biopsy-proven diagnosis of AL amyloidosis who achieved at least partial response after chemotherapy, who are not planned to receive further chemotherapy and who have significant cardiac dysfunction will be considered eligible. The patients will be stratified according to the quality of hematologic response and to the severity of cardiac involvement. Following stratification, the patients will be randomized to receive SST or SST plus EGCG. The study comprises 3 periods: screening (including stratification and randomization), treatment (with evaluations of response every 2 months) followed by the end-of-treatment evaluation and follow-up. Therapy will continue for up to 1 year. After treatment patients will be followed for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Diagnosis of AL amyloidosis.
- •Age ≥18 years.
- •The patients must have been treated for AL amyloidosis attaining hematologic response.
- •Evidence of cardiac involvement at echocardiography (mean left ventricular wall thickness >12 mm in the absence of other causes).
- •NT-proBNP ≥650 ng/L
排除标准
- •Non-AL (e.g. familial, senile) amyloidosis.
- •Concomitant non-amyloid related clinically significant cardiac diseases.
- •Need of further chemotherapy for AL amyloidosis.
- •Estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m
- •Uncontrolled infection.
- •Inability to give informed consent.
- •Previous or ongoing psychiatric illness (excluding reactive depression).
- •Pregnant or nursing women.
研究组 & 干预措施
Arm A
The patients will be divided into 4 strata according to cardiac dysfunction and to the quality of hematologic response. After stratification the patients will be randomized (1:1) within each stratum to receive Standard Therapy alone (Arm A) or Standard Therapy plus Investigational Drug (Arm B).
干预措施: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias) (Drug)
Arm B
The patients will be divided into 4 strata according to cardiac dysfunction and to the quality of hematologic response. After stratification the patients will be randomized (1:1) within each stratum to receive Standard Therapy alone (Arm A) or Standard Therapy plus Investigational Drug (Arm B)
干预措施: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCG (Drug)
结局指标
主要结局
Cardiac response
时间窗: 6 months
The primary objective is to assess whether treatment with EGCG increases the rate of cardiac response following chemotherapy in patients with AL amyloidosis. The primary endpoint is cardiac response at 6 months.
次要结局
- Time to cardiac progression(6 months)
- Rate of cardiac progression(6 months)
- Survival(6 months)
- Rate of adverse events(6 months)
- Rate of cardiac events(6 months)
- Time to cardiac events(6 months)
研究者
Giampaolo Merlini
Director, Amyloidosis Research and Treatment Center
Fondazione IRCCS Policlinico San Matteo di Pavia