NCT04852692终止不适用
A Retrospective/Prospective, Multicenter, Non-interventional, Historical Control Study Investigating Comparative Effectiveness of IMBRUVICA in Steroid Dependent/Refractory cGVHD Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Part A and Part B: Percentage of Participants with Overall Response Rate
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (modified National Institutes of Health [NIH] response defined complete response [CR] and partial response [PR]) at Week 24.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part A and Part B
- •Must have a confirmed diagnosis of steroid dependent or refractory classic cGVHD defined at any time post-hematopoietic cell transplantation (HCT) as: a) refractory disease - progressive cGVHD manifestations requiring prednisolone at greater than or equal to (>=) 1 milligram per kilogram per day (mg/kg/day) for at least 1 week or persist without improvement despite continued treatment with glucocorticoid (prednisolone at >= 0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks; b) dependent disease: persistent cGVHD manifestations requiring glucocorticoid >= prednisolone 0.25 mg/kg/day or >=0.5mg/kg every other day for at least 8 weeks Part A
- •Treated at least 2 or more therapies for cGVHD (including glucocorticoids)
- •Participants whose identified last line of conventional salvage treatment is second-fourth line of therapy
- •Index date (initiation date of the identified last-line of conventional salvage therapy) at least 28 weeks before the study initiation date Part B
- •Treated at least 3 lines therapies for cGVHD (including glucocorticoids)
- •Participants who are treated with ibrutinib in their second-fourth line of therapy
排除标准
- •Part A and Part B
- •Known or suspected active acute GVHD
- •Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days Part A
- •Treated with an investigational agent for their identified last-line of conventional salvage therapy
- •Pregnant, breastfeeding during last-line of conventional salvage therapy Part B
- •Pregnant, breast-feeding, or of childbearing potential without a negative serum or urine pregnancy test within 7 days of enrollment. Male or female participants of childbearing potential unwilling to use effective contraceptive precautions throughout the trial
结局指标
主要结局
Part A and Part B: Percentage of Participants with Overall Response Rate
时间窗: Week 24
Overall response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) according to modified National Institutes of Health (NIH) response.
次要结局
- Part A and Part B: Corticosteroid Requirement Changes Over Time(Up to 24 weeks)
- Part B: Time to cGVHD Progression(Up to 36 weeks)
- Part B: Rate of Sustained Response(At least 5 months (up to 36 weeks))
- Part B: Duration of Response(Up to 5 months)
- Part B: Change in Lee cGVHD Symptom Scale(Up to 36 weeks)
研究者
研究点 (8)
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