Rituximab in Life Threatening Therapy Resistant Progressive Interstitial Pneumonitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pulmonary function (VC, DLCO)
研究概览
简要总结
This project will address rare immune mediated inflammatory diseases (IMIDs) involving the lungs, i.e. interstitial pneumonitis (IP). The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for progressive IMID-IP patients. The primary study parameter is pulmonary function.
The secondary objectives are to explore the application of imaging with radiolabeled RTX as early predictor for efficacy of RTX, to study the effects of RTX treatment on quality of life, and to further elucidate the pathophysiology of IMID-IP by analyzing biochemical markers.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in the study, subjects must meet all of the following criteria:
- •Age 18 to 70 years
- •No previous therapy with rituximab
- •At least 2 pulmonary function tests within past 6 months
- •Diagnosis of co-existing IMID and a severe and / or progressive IP characterized by 3 out of the following items:
- •Respiratory symptoms consistent with interstitial lung disease
- •Diagnosis of usual interstitial pneumonia (UIP), non-specific interstitial pneumonia (NSIP), organizing pneumonia (OP) or a mixed form of UIP / NSIP / OP by either of the following:
- •Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP / NSIP / OP
- •High Resolution Computer Tomography (HRCT) scan showing definite or probable UIP/NSIP/OP/mixed
- •Forced Vital Capacity (FVC) < 50% predicted and/or diffusing capacity of the lung for carbon monoxide (DLCO) < 40% predicted or worsening of lung function as demonstrated by any one of the following within the past year:
- •> 10% decrease in FVC
- •> 15% decrease in DLCO
- •Therapy resistance to 1st (corticosteroids) and 2nd line therapy(cyclophosphamide or azathioprine)
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Residual volume >120% predicted at screening
- •DLCO <25% of predicted value at screening + resting Oxygen Saturation (SAO2) without external oxygen <90%
- •History of unstable or deteriorating cardiac or neurological disease
- •Pregnancy or lactation
- •Hematology lower than specified limits (leucocytes)
- •Positive HIV, hepatitis B or C serology
- •Pre-existing conditions which lead to a life expectancy of less than 6 months
- •Receipt of any vaccine, particularly live viral vaccines, within 4 weeks before first rituximab dose
- •Hypersensitivity for murine proteins
- •Fever (>37,9 °C) at presentation is reason to delay therapy by 1 week
- •Evidence of active infection is reason to postpone rituximab treatment until no further signs of active infection
- •Severe renal impairment is not a contraindication for rituximab therapy, however, if patients (might) require dialysis frequently they will be excluded from the study group
研究组 & 干预措施
rituximab
single arm study with Zr-89-rituximab immuno PET/CT
干预措施: Zr-89-rituximab immuno PET/CT (Radiation)
rituximab
single arm study with Zr-89-rituximab immuno PET/CT
干预措施: Rituximab (Drug)
结局指标
主要结局
Pulmonary function (VC, DLCO)
时间窗: 6 - 12 months
establish a change from the downward decline in pulmonary function (absolute values and values predicted of VC = Vital Capacity and DLCO = Diffusion capacity of Lung Carbon monoxide)
次要结局
- Zr-89 Immuno PET(3, 6 days after injection)
研究者
Human Adams
Prof. Dr. D.H. Biesma
St. Antonius Hospital