NCT07694414尚未招募1 期
Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse Events
Inge Marie Svane1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence and severity of rituximab-related adverse events graded according to CTCAE v. 6.0
研究概览
简要总结
The goal of this clinical trial is to investigate the safety of rituximab for management of immune-related adverse events in malignant melanoma patients. The main questions it aims to answer are:
- Is rituximab safe for management of immune-related adverse events in malignant melanoma patients?
- Does rituximab provide indications of clinical benefit in the management of immune-related adverse events compared with corticosteroid treatment alone?
Participants will:
- Receive a single dose of 100 mg rituximab IV
- Have regular follow-up consultations for 6 months following rituximab infusion
- Follow a simultaneous corticosteroid tapering plan
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed malignant melanoma diagnosis
- •Treatment with immune checkpoint inhibitors (anti-PD1, anti-PDL1, anti-LAG3 and/or anti-CTLA4) due to melanoma within 3 months
- •Any irAEs grade 2-4 according to CTCAE v. 6.0
- •Negative pregnancy test (serum hCG) in women of childbearing potential
- •Age ≥ 18 years
- •Ability to provide written and oral consent
- •The patient is able to understand and read Danish
排除标准
- •Any ongoing infectious disease
- •Neutropenia (<1.5 x10^9/L) and/or thrombocytopenia (<75 x10^9/L)
- •Known hypersensitivity towards the active substance rituximab or any of the excipients
- •History of cardiovascular disease including severe heart failure NYHA grade 3-4, unstable angina pectoris, atrial fibrillation, atrial flutter, and myocardial infarction
- •Any major wounds
- •Low baseline IgG (<6 g/L)
- •Positive hepatitis B virus, hepatitis C virus, HIV, or tuberculosis screening
- •Concomitant immunosuppressive medication except prednisolone
- •Concomitant chemotherapy or other antineoplastic therapy (except checkpoint inhibitor therapy) within 30 days prior to inclusion
- •Females of childbearing potential or males of reproductive potential who are not willing to use an effective method of contraception, such as oral, injected, or implanted hormonal methods of contraception, intrauterine device or intrauterine system, condom in combination with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream or suppository, male sterilization, or true abstinence throughout study and for a minimum of 3 months after study drug therapy.
研究组 & 干预措施
Rituximab
Experimental
干预措施: Rituximab (RTX) (Drug)
结局指标
主要结局
Incidence and severity of rituximab-related adverse events graded according to CTCAE v. 6.0
时间窗: Until 6 months post treatment
Safety of rituximab is evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) v. 6.0 and include the incidence and severity of rituximab-related adverse events until 6 months post treatment.
次要结局
- Immune-related adverse event management response(Until 6 months post treatment)
- Corticosteroid dependency(Until 6 months post treatment)
- Dose of corticosteroids(Until 6 months post treatment)
- Second- or third-line immunosuppressants(Until 6 months post treatment)
研究者
Inge Marie Svane
Professor, MD, PhD
Herlev Hospital
研究点 (1)
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