Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination
研究概览
简要总结
This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.
详细描述
This is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. Data will be collected at baseline (retrospectively), 100 days post alloHCT, 6-months, 1 year and at 2 years post alloHCT (retrospectively and prospectively).
A cut-off time limit of 18 months post alloHCT exposure will allow at least 6 months of follow-up within the 2 years post-alloHCT follow-up period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)
- •Adults ≥18 years of age with either CTCL or ATLL;
- •AlloHCT performed from January 2012 onward.
排除标准
- •Patients without consent for research.
结局指标
主要结局
Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination
时间窗: one year prior to alloHCT to within 18 months after alloHCT
This study will utilize comprehensive report form (CRF) data, modified transplant essential data (TED) and supplemental data. In patients with only TED data the supplemental data will provide the required additional information for data analyses to meet the objectives of the study.
次要结局
未报告次要终点