A Non-interventional, Long-term Follow-up of Subjects Who Completed ApoGraft-01 Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence, grade and stage of acute GvHD and chronic GvHD
研究概览
简要总结
This is a non-interventional, long-term follow-up study in subjects who received ApoGraft in study ApoGraft-01. Up to 12 subjects who completed ApoGraft-01 study will be offered to participate in this follow-up study.
Subjects who completed ApoGraft-01 study and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend in-clinic visits up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence), physical examination, safety laboratory and concomitant medication use.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed study ApoGraft-01 through 180 days (6 months) post-transplantation
- •Ability to comply with the requirements of the study.
- •Signed written informed consent
排除标准
- 未提供
结局指标
主要结局
Incidence, grade and stage of acute GvHD and chronic GvHD
时间窗: 18 months
GVHD will be assessed according to NIH criteria 2005; current and maximal score at each visit.
次要结局
- Non-relapse-related mortality(18 months)
- Proportion of subjects with disease relapse/recurrence(18 months)
- Proportion of subjects with relapse free and overall survival(18 months)