Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study - Intervention Pilot Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Infusional reactions
研究概览
简要总结
The objective of this pilot study is therefore to assess the safety of Truxima ultrafast infusion within 30 minutes in patients with non-Hodgkin's lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have tolerated the maximum rate of intravenous administration of rituximab (400 mg/h) in the first or second infusion.
- •The last rituximab infusion must have occurred within the last 3 months.
- •All patients receiving rituximab can be included, regardless of whether they receive rituximab as monotherapy or in combination with chemotherapy and regardless of the line in which they are receiving it.
- •Patients will be included in both induction and maintenance treatment.
- •All patients must sign the informed consent form.
排除标准
- •Patients with initial absolute lymphocyte count >10x10^3 cells/µL.
- •Patients who have presented hypersensitivity and severe adverse effects (grade II or higher) in the first or second infusion.
- •Severe heart failure (NYHA class III-IV) or uncontrolled severe cardiac disease.
- •Respiratory failure, severe uncontrolled COPD/asthma.
- •Patients allergic to premedication: acetaminophen or polaramine.
- •Severe active infection.
- •Pregnant patients.
- •Refusal to participate.
研究组 & 干预措施
Rapid infusion group
After the administration of intravenous premedication (usually dexchlorpheniramine 5 mg IV and paracetamol 1 g IV), rituximab will be administered at standard dose (375 mg/m2 diluted in 250 ml of saline) administered in one hour, divided into: 10 first minutes at 450 mg/hour, and 50 minutes later at 720 mg/hour.
干预措施: RiTUXimab Injection [Truxima] (Drug)
Ultrarapid infusion group
After the administration of intravenous premedication, the dose of rituximab will be administered at standard dose administered in half an hour, divided into: 10 first minutes at 450 mg/hour, and 20 minutes later at 1800mg/hour.
干预措施: RiTUXimab Injection [Truxima] (Drug)
Ultrarapid plus infusion group
After the administration of oral premedication, the dose of rituximab will be administered at the standard dose administered in half an hour, divided into: 10 first minutes at 450 mg/hour, and 20 minutes later at 1800mg/hour.
干预措施: RiTUXimab Injection [Truxima] (Drug)
结局指标
主要结局
Infusional reactions
时间窗: 24 hours
Percentage of grade 2/3 or higher infusion reactions in rapid, ultrafast and ultrafast plus infusion compared to rituximab administration following standard clinical practice at standard rate of 400 mg/h.
次要结局
未报告次要终点
研究者
Laida Cuevas Palomares
Dr. specialist in hematology and hemotherapy
Bioaraba Health Research Institute