NCT04289103Unknown3 期
A Phase 3, Multicenter, Open Label, Study to Evaluate the EFficacy and SaFEty of Leukotac® (Inolimomab) in Pediatric Patients With Steroid Resistant Acute Graft Versus Host Disease (SR-aGvHD)
ElsaLys Biotech0 个研究点目标入组 65 人开始时间: 2021年10月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 65
- 主要终点
- Overall response
研究概览
简要总结
A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)
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
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who develop a first episode of aGvHD stage ≥ II (Przepiorka et al., 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose)
- •Age 28 days to < 18 years old
- •Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
- •Patients receiving Allo-HSCT for any indication (i.e. malignant or non-malignant disease)
- •Signature of informed and written consent by the patient and/or by the patient's legally acceptable representative(s)
排除标准
- •Isolated stage 1 skin SR-aGvHD
- •Overlap chronic GvHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
- •Acute GvHD after donor lymphocytes infusion (DLI)
- •Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
- •Other systemic drugs than corticosteroids for GvHD treatment (including extra-corporeal photopheresis). Drugs already being used for GvHD prevention (e.g. calcineurin inhibitors) are allowed.
- •Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
- •Known allergy or intolerance to Leukotac of one of its ingredients
- •Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female and male of childbearing potential
- •Other ongoing interventional protocol that might interfere with
结局指标
主要结局
Overall response
时间窗: Day 29 post inclusion
Complete response + very good partial response + partial response
次要结局
未报告次要终点
研究者
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