EUCTR2018-002253-30-GB进行中（未招募）1 期
An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Itacitinib in Combination With Corticosteroids for the Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Pediatric Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female subjects from 28 days to < 18 years old
- •Undergone 1 allo-HSCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.
- •Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylactic medication. Efforts should be made to obtain biopsies to pathologically confirm aGVHD. In cases where a biopsy is negative, unable to be obtained, or clinically contraindicated, clinical suspicion of aGVHD by the treating physician is sufficient, provided that alternative diagnoses of drug effects or infection are adequately ruled out.
- •Evidence of myeloid engraftment (eg, absolute neutrophil count [ANC] = 0.5 × 109/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed.
- •Glomerular filtration rate (GFR) > 50 mL/min/1.73 m2 as estimated using modified Schwartz formula.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •More than 1 allo-HSCT.
- •Received more than 2 days of systemic corticosteroids for aGVHD before the first study drug administration.
- •Presence of GVHD overlap syndrome.
- •Presence of an active uncontrolled infection, defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection.
研究者
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