Childhood Leukemia Antifungal Prophylaxis (CLAP) study: A Prospective, multi-arm multi stage randomized phase III, open label study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- To estimate the efficacy of various antifungal prophylaxis in preventing IFI in children with acute lymphoblastic leukemia during the induction and consolidation phases of therapy.
研究概览
简要总结
The study discusses how invasive fungal infections (IFI) are increasingly affecting children with newly diagnosed acute lymphoblastic leukemia (ALL) and acute lymphoblastic lymphoma (LBL) who are undergoing intensive chemotherapy. According to a review of patient records at their center, about 23% of 420 patients developed some form of IFI, with 11.5% having confirmed or likely fungal infections. Most of these infections were caused by molds and typically occurred during the initial stages of treatment, especially in patients with T-cell ALL/LBL. The paragraph also discusses different antifungal medications like voriconazole, posaconazole, and micafungin, which are used to prevent these infections. It emphasizes the need for more research, like randomized controlled trials, to determine the best ways to prevent fungal infections, especially since different medications have varying levels of effectiveness in different regions and among different patient groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •High risk B-acute lymphoblastic leukemia Intermediate risk B Cell Acute Lymphoblastic Leukemia.
- •B Cell lymphoblastic lymphoma.
- •T Cell Acute Lymphoblastic Leukemia T Cell Lymphoblastic Lymphoma.
- •During induction phase of therapy.
- •Total bilirubin should be less than 1.5 x upper limit of normal for age.
- •SGOT or SGPT less than 5 x ULN for age.
排除标准
- •Standard risk Acute Lymphoblastic Leukemia Patients with ALL for whom risk-group is unavailable.
- •Patients with a history of allergy to any of the study drugs.
- •A documented history of Invasive Fungal Infection within 30 days prior to randomization.
- •Patients on treatment for Invasive Fungal Infection.
- •Patients not consenting for the study.
结局指标
主要结局
To estimate the efficacy of various antifungal prophylaxis in preventing IFI in children with acute lymphoblastic leukemia during the induction and consolidation phases of therapy.
时间窗: Assessments will be done on at the start and end of the induction and consolidation phases of therapy
次要结局
- To asses mortality due to any cause.(During the course of antifungal treatment.)
- To assess proven or probable IFI related invasive fungal infection related mortality.(During the course of antifungal treatment.)
- To assess the incidence of IFI, including invasive aspergillosis, candidiasis, mucor and any(other IFI.)
- To assess prophylaxis failure. This would be defined as a development of proven or(probable IFI as defined above or the occurrence of an adverse event possibly or)
- Corelate voriconazole and posaconazole serum levels whenever available with drug doses and breakthrough IFI.(During the course of antifungal treatment.)
研究者
Dr Shyam Srinivasan
Tata Memorial Hospital