Pilot Study on the Reduced Intravenous Fluids to Improve Clearance of High-Dose Methotrexate (HDMTX) in Children With Lymphoma or Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L
研究概览
简要总结
To determine whether a reduced volume hydration regimen will lead to a shorter time to methotrexate clearance when compared to a standard intravenous (IV) hydration regimen.
详细描述
This study uses a prospective randomized controlled crossover study design. Neither patients nor clinicians are blinded to the standard versus reduced intravenous fluids (IVF) regimen. Patients are randomized to begin with standard volume or reduced volume IVF. Over the course of 4 cycles of High Dose Methotrexate (HDMTX), patients alternate between standard and reduced volume post hydration fluids protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lymphoma or acute lymphoblastic leukemia
- •Candidate for a minimum of 2 cycles HDMTX (5 g/m2) in the inpatient setting
- •Creatinine clearance ≥ 65 mL/min by modified Schwartz equation
- •Patients of childbearing potential must have a negative pregnancy test (serum or urine)
- •Lactating female patients must agree not to nurse a child while on this trial
- •All patients and/or their parents or legal guardians must provide written informed consent, with assent provided if applicable
排除标准
- •Trisomy 21
- •History of dialysis within 30 days prior to study registration or currently on dialysis
- •Polyuric renal dysfunction
- •Pregnancy
- •Known or suspected pleural effusion
- •Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
研究组 & 干预措施
Standard Hydration Regimen
In the standard intravenous fluid (IVF) protocol, following completion of HDMTX infusion, post HDMTX IVF will be initiated at 125 mL/m2/hr (no maximum mL/hr total rate).
干预措施: Intravenous fluids (Drug)
Reduced hydration regimen
The reduced intravenous fluid (IVF) protocol, post HDMTX IVF will be initiated at 62.5 mL/m2/hr following completion of HDMTX infusion.
干预措施: Intravenous fluids (Drug)
结局指标
主要结局
Time elapsed (in hours) from end of HDMTX to a serum methotrexate level <0.1 micromol/L
时间窗: 63 Days
To determine whether a reduced volume hydration regimen will lead to a shorter time to methotrexate clearance when compared to a standard IV hydration regimen by measuring serum methotrexate levels twenty-four hours following the end of the high dose methotrexate ( HDMTX) infusion, and continuing every twelve hours until the methotrexate level is less than 0.1 micromol/L.
次要结局
- Markers of kidney toxicity(84 Days)
- Effects on therapy delays(84 Days)
- Markers of fluid overload(84 Days)
- Effects on development of severe mucositis(84 Days)