Implementation of Rapid Infusion Rituximab in a Pilot Group of Adolescents With Hematologic, Oncologic, and Rheumatologic Disorders
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine the safety of rapid infusion rituximab in a pilot group of adolescent patients for hematologic, oncologic, and rheumatologic disorders.
研究概览
简要总结
Rituximab is frequently used in adult and pediatric cancers, blood disorders, lymphoma (a cancerous growth made up of lymphoid tissue), graft-versus-host-disease (complication that can occur after a stem cell or bone marrow transplant), diseases of the immune system (the cells and substances that protect the body from infection) and rheumatologic conditions. Rituximab works by decreasing or temporarily eliminating a specific type of white blood cell, the B-lymphocyte. Overall, rituximab is generally well tolerated. The likelihood of an infusion-related reaction, or symptoms such as fever, chills, hives, low blood pressure or swelling, is very low, but highest during a patient's first infusion of rituximab and decreases with each additional dose. Adults commonly receive rituximab at a faster rate if they have done well with the first infusion, this study will help determine if the same approach is well tolerated in children.
In this study, the investigators are testing a new method of administering rituximab which may reduce the time it takes to receive the medication. The initial ordered amount of rituximab will not change from the current standard of care (meaning what is usually done by doctors, and would likely be done if you were not on this study). The period of time over which rituximab is given is what is being studied.
详细描述
The standard of care in patients receiving rituximab is to give the dose slowly and gradually increase the rate of rituximab until the full dose is given, which may take several hours. This is done in order to prevent a side effect of rituximab called an infusion reaction. Infusion reactions are similar to allergic reactions and may cause symptoms such as low blood pressure, wheezing, chest tightness, fever, itching, bad cough, blue skin color, seizures, or swelling of the face, lips, tongue, or throat.
In this study, the investigators are testing the method of giving rituximab over a shorter period of time. Administering rituximab at this faster rate is done commonly and safely in the adult population with very few side effects.
The drug rituximab will be given as an infusion in the outpatient clinic. Infusion means the drug is given using a needle or tubing inserted into a vein (also called an IV) over a period of time.
If patients have a cancer or blood disorder, they will receive rituximab administration over 90 minutes, 20% of the dose will be given over the first 30 minutes and the remaining 80% of the dose will be given over 60 minutes. This is the standard method of infusing doses of rituximab in adults who have a cancer or blood disorder, and have done well with a first dose of rituximab at the standard infusion rate.
If patients have a rheumatologic disease, they will receive rituximab administration over 120 minutes, 12.5% of the dose will be given over the first 30 minutes and the remaining 87.5% of the dose will be given over 90 minutes. This is the standard method of infusing doses of rituximab in adults who have a rheumatologic disorder, and have done well with a first dose of rituximab at the standard infusion rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously received and tolerated at least one rituximab infusion via standard infusion administration. *No modifications or adjustment to the infusion, or treatment with any anaphylaxis reaction medications required
- •No history of Grades 3 or 4 infusion reaction to rituximab based on the NIH Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
- •Prescribed rituximab with the following indications and doses for administration in the outpatient setting:
- •Hematologic or oncologic indication: 100 mg/m^2 or 375 mg/m^2
- •Rheumatologic indication: 375-750 mg/m^2 (total dose not to exceed 1000 mg)
排除标准
- •Any patient not meeting the inclusion criteria.
- •Any patient who does not consent to the pilot protocol.
- •Any patient on a clinical trial where the infusion rate of rituximab is prescribed by the clinical trial.
- •Any patient who required rescue or symptomatic treatment with steroids, antihistamines, or epinephrine during prior rituximab infusions.
- •Any patient who has received a bone marrow transplant.
研究组 & 干预措施
Rheumatologic disease
Rituximab is administered over 120 minutes, 12.5% of the dose will be given over the first 30 minutes and the remaining 87.5% of the dose will be given over 90 minutes.
干预措施: Rituximab (Drug)
Cancer or blood disorder
Rituximab is administered over 90 minutes, 20% of the dose will be given over the first 30 minutes and the remaining 80% of the dose will be given over 60 minutes.
干预措施: Rituximab (Drug)
结局指标
主要结局
To determine the safety of rapid infusion rituximab in a pilot group of adolescent patients for hematologic, oncologic, and rheumatologic disorders.
时间窗: 6 weeks
To be measured by the administration of rapid infusion rituximab without requiring modifications to therapy as a result of adverse reactions
次要结局
- To determine the incidence of infusion-related reactions with the administration of rapid infusion rituximab(6 weeks)
研究者
Jenny Despotovic
Assistant Professor
Baylor College of Medicine