2023-510253-42-00招募中2 期
NUCastle - Nintedanib treatment in Unicentric Castleman disease
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Best response over 6 months defined as >30% decrease from baseline in Total Lesion Glycolysis (TLG) measured by 18F FDG PET/CT performed at M3 and M6
研究概览
简要总结
Evaluate the efficacy of nintedanib in decreasing Total Lesion Glycolysis (TLG) of the UCD lesion over a 6-month treatment.
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 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age equal to or greater than18 years
- •Written informed consent
- •Biopsy-proven diagnosis of hyaline-vascular Unicentric Castleman disease
- •Unresectable or partially resectable UCD lesion or surgery refusal
- •Available oral route
- •Affiliated to National French social security system (registered or being a beneficiary of such a scheme)
排除标准
- •Synchronous Follicular Dendritic Cell sarcoma
- •Uncontrolled systemic illness such as, chronic heart failure, unstable angina, hypertension, history or myocardial infarction in the 12 months prior to the start of the treatment
- •Major injuries in the 10 days prior to start of the study / Recent surgery with wound healing in progress (<14 days)
- •Bleeding risk, any of the following : a. Known genetic predisposition to bleeding. b. Patients who require
- •Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin)
- •High dose antiplatelet therapy corresponding to a combination of two anti-platelet aggregation treatment (aspirin + an Inhibitor of P2Y12 receptor).
- •Contraindication to the experimental drug or auxiliary drugs listed in section 7.3
- •Enrolment in another interventional study(ongoing at the time of inclusion)
- •Known hypersensitivity to nintedanib, soy or peanut
- •For women of childbearing age: positive serum or urine pregnancy test at inclusion and during the study period, up to 3 months after the last dose (plasmatic at inclusion)
- •Inability to obtain informed consent
- •Patients under guardianship or curatorship and protected adults
- •Liver transaminases (AST and/or ALT) >5N
- •End-stage liver disease (Child B or C cirrhosis)
- •End-stage renal failure (CrCl<30 mL/min)
- •Severe hemorrhagic or thromboembolic events in the past 6 months
结局指标
主要结局
Best response over 6 months defined as >30% decrease from baseline in Total Lesion Glycolysis (TLG) measured by 18F FDG PET/CT performed at M3 and M6
Best response over 6 months defined as >30% decrease from baseline in Total Lesion Glycolysis (TLG) measured by 18F FDG PET/CT performed at M3 and M6
次要结局
- Number of adverse events (AEs), number of serious AEs, nindetanib discontinuation up to Month 9 (M9)
- Variation from baseline in size, SUV and TLG percentage of the lesion at M3 and M6
- Change in the status of non-resectability of the UCD lesion at M6
- Evolution of autoimmune-related complications: *Paraneoplastic pemphigus/Bronchiolitis Obliterans: Improvement/Worsening/ Stable disease based on: - pemphigus disease area index (for PNP) at M1, M3, M6 and M9 - bronchiolitis obliterans: change from baseline of the percent of predicted forced expiratory volume in 1 second (FEV1), in forced vital capacity, total lung capacity and DLCO at M3, M6 and M9 - serum antibody titers (anti desmoglein 1/3,anti desmoplakin,anti envoplakin, anti periplakin)
- Occurrence of paraneoplastic pemphigus and/or myasthenia gravis during follow-up, up to M9
- Evaluation of the mutational status of PDGFRB of the lesion (NGS technology) and correlation with treatment response (variation in size, SUV, TLG at M3 and M6)
- Nintedanib residual plasma concentration at M1, M3, M6
研究者
Investigateur coordinateur
Scientific
Assistance Publique Hopitaux De Paris
研究点 (5)
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