A Study of Ruxolitinib in Patients With Graft-Versus Host Disease
2026年6月5日 更新者：Novartis Pharmaceuticals
Post-marketing Database Study in Patients With Graft-Versus Host Disease for JAKAVI Tablets
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.
研究概览
地位
招聘中
条件
研究类型
观察性的
注册 (估计的)
395
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Novartis Pharmaceuticals
- 电话号码：+41613241111
- 邮箱：novartis.email@novartis.com
研究联系人备份
- 姓名：Novartis Pharmaceuticals
学习地点
-
-
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Tokyo、日本、105-6333
- 招聘中
- Novartis
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients treated with ruxolitinib for acute and chronic GVHD after its approval.
描述
Inclusion Criteria:
- Patients with acute and chronic GVHD
- Patients treated with ruxolitinib
Exclusion Criteria:
None
Other protocol-defined inclusion/exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Ruxolitinib Cohort
Patients with acute and chronic GVHD treated with ruxolitinib.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections
大体时间：Up to 1 year
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Grade ≥ 3 infections according to the CTCAE v5.0.
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Up to 1 year
|
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Number and Percentage of Deaths Due to Infection
大体时间：Up to 1 year
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Up to 1 year
|
|
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Time to First Event
大体时间：Up to 1 year
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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.
|
Up to 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number and Percentage of CTCAE Grade ≥ 3 Infections
大体时间：Up to 1 year
|
Grade ≥ 3 infections according to the CTCAE v5.0.
|
Up to 1 year
|
|
Odds Ratio of CTCAE Grade ≥ 3 Infections
大体时间：Up to 1 year
|
Odds ratios of infections and their 95% confidence intervals summarized by risk factors for infection.
|
Up to 1 year
|
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Number and Percentage of Patients With Adverse Events Other Than Infections
大体时间：Up to 1 year
|
Up to 1 year
|
|
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Number and Percentage of Patients who Died From Reasons Other Than Infection
大体时间：Up to 1 year
|
Up to 1 year
|
|
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Time to First Onset of Bone-related Events
大体时间：Up to 1 year
|
The time to the first onset is defined as the time from the start date of treatment with ruxolitinib to the first onset date of CTCAE Grade ≥ 4 fracture or bone-related events other than fracture.
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Up to 1 year
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Overall Response Rate (ORR) Among Patients With Acute GVHD
大体时间：Day 28
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ORR is defined as the proportion of patients with complete response (CR) or partial response (PR).
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Day 28
|
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Number and Percentage of Stages of Disorder for Each Organ Among Patients With Acute GVHD
大体时间：Baseline, Day 28, up to 1 year
|
Baseline, Day 28, up to 1 year
|
|
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ORR Among Patients With Chronic GVHD
大体时间：Month 6
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ORR is defined as the proportion of patients with CR or PR.
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Month 6
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Number and Percentage of Chronic GVHD Patients by Response
大体时间：Baseline, Month 6, up to 1 year
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Response (CR, PR, mixed response, no change, progression) as entered into the database by the physician in accordance with the Japanese Society for Transplantation and Cellular Therapy guidelines for hematopoietic cell transplantation.
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Baseline, Month 6, up to 1 year
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Best Overall Response (BOR)
大体时间：Baseline, up to 1 year
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BOR is defined as the proportion of patients with CR or PR at any time point up to Month 12 of treatment.
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Baseline, up to 1 year
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Overall Survival
大体时间：Up to 1 year
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Overall survival is defined as the time from the start date of treatment with ruxolitinib to the date of death due to any cause.
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Up to 1 year
|
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Duration of Response (DOR) Among Chronic GVHD Patients
大体时间：Up to 1 year
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DOR is defined for patients who achieved a response (CR or PR) by Month 12 of treatment as the time from the date of first documented response by Month 12 to the date of a DOR event (progression of chronic GVHD, death, or initiation of new systemic therapy for chronic GVHD, whichever occurs first).
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Up to 1 year
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Time to Response (TTR) Among Chronic GVHD Patients
大体时间：Up to 1 year
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TTR is defined as the time from the start date of treatment with ruxolitinib to the date of first confirmed response (CR or PR).
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Up to 1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Novartis Pharmaceuticals、Novartis Pharmaceuticals
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月11日
初级完成 (估计的)
2030年5月15日
研究完成 (估计的)
2030年5月15日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月19日
研究记录更新
最后更新发布 (实际的)
2026年6月8日
上次提交的符合 QC 标准的更新
2026年6月5日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.