An Exploratory Phase 1/2 Clinical Trial Evaluating ALD518 in Subjects With Glucocorticoid-Refractory Acute Graft vs. Host Disease (GVHD) After Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- CSL Behring
- 入组人数
- 3
- 试验地点
- 10
- 主要终点
- Number of Participants With Adverse Events, Including Infections and Loss of Engraftment
研究概览
简要总结
The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further investigation in Part B.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glucocorticosteroid refractory acute GVHD Grade 2-4
- •Prior corticosteroid therapy at > 1.0mg/kg methylprednisolone or equivalent for minimum of 3 and maximum of 14 days
- •Karnofsky Performance Satus Scale ≥ 50%
- •Adequate laboratory testing at screening
排除标准
- •Subjects having Stage 1 skin acute GVHD
- •Subjects with Stage 3 or 4 liver GVHD
- •Prior EBV associated malignancy
- •Prior or current Hepatitis B or C
- •Prior or active tuberculosis
结局指标
主要结局
Number of Participants With Adverse Events, Including Infections and Loss of Engraftment
时间窗: Through Week 24
Number of Participants With Acute GVHD Response at Week 4
时间窗: Week 4
Includes calculation of both complete and partial response. Complete response = functional grade of 0 for the GVHD grading in all evaluable organs. Partial response = improvement by one or more functional grades in one or more organs involved with GVHD symptoms without progression in others, or a very good partial response which is a partial response plus all of the following: (1) skin - active erythematous rash involving less than 25% of body surface, (2) liver - total bilirubin \<2 mg/dL or a 25% reduction from baseline (if \>2 mg/dL), (3) gut - greater than or equal to 75% reduction in daily stool volume.
次要结局
- Number of Participants With Relapse of Underlying Malignant Disease(Through Week 24)
- Number of Participants With Overall Survival(Through Week 24)
- Change in Patient Reported Outcomes as Measured by the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Questionnaire Score(Up to 20 weeks)