Prediction of Rituximab Hypersensitivity and Desensitization Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Predictive value of skin test
研究概览
简要总结
This is a single-center prospective single arm study. The purpose of this study is to assess the usefulness of skin test as a diagnostic tool to predict the hypersensitivity to rituximab in Chinese population, evaluate the rate of hypersensitivity reactions (HSRs) after the application of active desensitization therapy in the case of a positive skin test result, and investigate the mechanism of HSRs to rituximab.
详细描述
Patients with B-cell lymphomas who need the administration of rituximab are recruited. They undergo skin tests with rituximab before the first infusion of this medicine. In the case of a positive skin test result, the patient will receive the desensitization procedure; if the result of skin test is negative, the challenge test will be administered. Drug challenge test consists in administering the desired full dose of rituximab according to manufacturer instructions. Challenge is considered positive when it shows an objective HSR. The patient with a positive challenge test will receive the desensitization procedure; while the patient with a negative challenge test will be given standard rituximab infusion in the subsequent chemotherapies.
Peripheral blood will be drawn from all the subjects during their initial infusion of rituximab. If the patient shows hypersensitive symptoms, the blood will be drawn one hour after the onset of reaction; while if the patient has no HSR in the whole infusion process, the blood will be drawn at the end of infusion and used as negative control. Levels of tryptase, specific immunoglobulin E to rituximab, IL-6, IL-8, and TNF-α in the serum will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with B cell lymphoma confirmed through pathological biopsy
- •Patients who need the treatment of rituximab and have not received rituximab before
排除标准
- •Pregnant or lactating women
- •Patients taking antihistamines in three days before the skin tests
- •Long-term use of systemic corticosteroid
- •Patients with skin lesions including infection, dermatitis, trauma or scar in both arms
- •Patients with acute attack of asthma
- •Patients with psoriasis
- •Other conditions that the researchers consider inappropriate to participate in the trial
研究组 & 干预措施
Experimental group
Patients undergo diagnostic tests before the initial infusion of rituximab, including skin prick tests, intradermal tests, and challenge tests successively. If the skin test shows a positive result, the patient will receive desensitization procedure, and if the skin test is negative, the challenge test will be done, meaning normal infusion of rituximab according to manufacturer instructions. All the HSRs in the process of desensitization or normal infusion will be recorded. Peripheral blood will be drawn from all the subjects during their infusion to investigate the mechanism of HSRs to rituximab.
干预措施: skin test (Diagnostic Test)
结局指标
主要结局
Predictive value of skin test
时间窗: From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks
The sensitivity and specificity of skin test in the prediction of HSR to rituximab.
次要结局
- Specific immunoglobulin E to rituximab(From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks)
- IL-6(From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks)
- IL-8(From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks)
- Hypersensitivity reactions (HSRs)(From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks)
- Tryptase(From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks)
- TNF-α(From date of signing the informed consent until the end of induction chemotherapy, up to 32 weeks)