NCT07594587招募中不适用
Post-marketing Database Study in Patients With Graft-Versus Host Disease for JAKAVI Tablets
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Number and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections
研究概览
简要总结
This study aims to evaluate the safety and effectiveness of Jakavi® (ruxolitinib) in patients with acute graft-versus host disease (GVHD) and chronic GVHD in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute and chronic GVHD
- •Patients treated with ruxolitinib
排除标准
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Ruxolitinib Cohort
Patients with acute and chronic GVHD treated with ruxolitinib.
结局指标
主要结局
Number and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections
时间窗: Up to 1 year
Grade ≥ 3 infections according to the CTCAE v5.0.
Number and Percentage of Deaths Due to Infection
时间窗: Up to 1 year
Time to First Event
时间窗: Up to 1 year
Time to first event is defined as the time from the start date of treatment with ruxolitinib to the first onset date of infection. Grade ≥ 4 infections according to the CTCAE v5.0.
次要结局
- ORR Among Patients With Chronic GVHD(Month 6)
- Number and Percentage of CTCAE Grade ≥ 3 Infections(Up to 1 year)
- Odds Ratio of CTCAE Grade ≥ 3 Infections(Up to 1 year)
- Number and Percentage of Patients With Adverse Events Other Than Infections(Up to 1 year)
- Number and Percentage of Patients who Died From Reasons Other Than Infection(Up to 1 year)
- Time to First Onset of Bone-related Events(Up to 1 year)
- Overall Response Rate (ORR) Among Patients With Acute GVHD(Day 28)
- Number and Percentage of Stages of Disorder for Each Organ Among Patients With Acute GVHD(Baseline, Day 28, up to 1 year)
- Number and Percentage of Chronic GVHD Patients by Response(Baseline, Month 6, up to 1 year)
- Best Overall Response (BOR)(Baseline, up to 1 year)
- Overall Survival(Up to 1 year)
- Duration of Response (DOR) Among Chronic GVHD Patients(Up to 1 year)
- Time to Response (TTR) Among Chronic GVHD Patients(Up to 1 year)
研究者
研究点 (1)
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