South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
In recent years, the prognosis of pediatric relapsed ALL patients has improved, but the 5-year OS of patients with first recurrence is still less than 50%. A number of in vitro studies have shown that arsenic trioxide (ATO) can selectively inhibit the growth and induce apoptosis in a variety of leukemia cell lines, suggesting that ATO as a synergist combined with other common chemotherapy drugs may provide a new target for the treatment of relapsed ALL. Realgar Indigo naturalis formula is a compound traditional Chinese medicine preparation developed in China. The main component of realgar is arsenic tetrasulfide (As4S4), which can produce similar pharmacological effects to ATO. Based on the R3 protocol, this study plans to perform a double-blind randomized controlled trial, and to randomly combine compound Huangdai tablets with compound Huangdai tablets in the treatment of intermediate and high risk ALL children, in order to improve the MRD negative rate after induction therapy in this group of children, which may provide a new method for the clinical treatment of relapsed ALL.
详细描述
In recent years, the prognosis of pediatric relapsed ALL patients has improved, but the 5-year OS of patients with first recurrence is still less than 50%, and the prognosis of children with intermediate and high risk is even worse, so there is an urgent need to explore new and effective treatment methods. A number of in vitro studies have shown that arsenic trioxide (ATO), which is safe and effective in the treatment of APL, can selectively inhibit the growth and induce apoptosis in a variety of leukemia cell lines, suggesting that ATO as a synergist combined with other common chemotherapy drugs may provide a new target for the treatment of relapsed ALL. Realgar Indigo naturalis formula is a compound traditional Chinese medicine preparation developed in China. The main component of realgar is arsenic tetrasulfide (As4S4), which can produce similar pharmacological effects to ATO. The UK ALL R3 protocol is an advanced and mature clinical trial. The results showed that the MRD negative rate after induction chemotherapy and the 2-year DFS of traditional chemotherapy ±HSCT in children with intermediate and high risk did not reach 50%. Based on the R3 protocol, this study plans to perform a double-blind randomized controlled trial, and to randomly combine compound Huangdai tablets with compound Huangdai tablets in the treatment of intermediate and high risk ALL children, in order to improve the MRD negative rate after induction therapy in this group of children, which may provide a new method for the clinical treatment of relapsed ALL.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •B or T cell type;
- •the first recurrence;
- •the risk stratification was medium or high risk.
排除标准
- •mature B cell leukemia;
- •acute mixed phenotype leukemia;
- •patients with positive BCR/ABL fusion gene;
- •the second tumor
- •definite CML blast crisis;
- •ALL with Down's syndrome.
研究组 & 干预措施
Control group
Oral placebo was added to conventional chemotherapy
干预措施: Conventional chemotherapy (Combination Product)
Experimental Group
Oral RIF was added to conventional chemotherapy
干预措施: Realgar Indigo naturalis formula (Drug)
Experimental Group
Oral RIF was added to conventional chemotherapy
干预措施: Conventional chemotherapy (Combination Product)
结局指标
主要结局
Complete response rate
时间窗: from diagnosis, an average of 7 weeks
Complete response rate after induction treatment in two groups
次要结局
未报告次要终点