A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have Received oNKord®
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of SAEs related to oNKord® over time
研究概览
简要总结
ReKORD is an observational study (Registry) enrolling participants who have received at least one dose of oNKord® (allogeneic ex vivo-generated Natural Killer [NK] cells from CD34+ umbilical cord blood progenitor cells) in a clinical trial. Participants from multiple previous clinical trials of oNKord® can be enrolled in this Registry.
详细描述
To be eligible for this Registry, participants must have received at least one dose of oNKord® in a clinical trial. Eligible participants will be enrolled after signing the informed consent form (ICF). Participant characteristics, treatment history, and clinical trial outcome data at clinical trial discontinuation/completion will be collected. On a yearly basis after the last clinical trial visit, the investigator will collect the participants' medical status and enter them in the Registry database. Major clinical events, including concomitant medication or therapy, that occurred since the previous assessment will be recorded. No protocol-specific visits or interventions will be required. Participants will be followed up until 3 years after the first oNKord® infusion.
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
- •Receipt of at least one dose of oNKord® in a clinical trial
- •Participation must be within 3 years after the first infusion of oNKord®
- •Signature of ICF
排除标准
- 未提供
研究组 & 干预措施
Participants having received oNKord® as part of the WiNK clinical trial
WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and not currently proceeding to hematopoietic stem cell transplantation
干预措施: oNKord® (Drug)
Participants having received oNKord® as part of the WiNK clinical trial
WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and not currently proceeding to hematopoietic stem cell transplantation
干预措施: Cyclophosphamide/Fludarabine (Cy/Flu) (Drug)
结局指标
主要结局
Incidence of SAEs related to oNKord® over time
时间窗: 3 years
Safety
Incidence of SAEs related to Cyclophosphamide-Fludarabine over time
时间窗: 3 years
Safety
Long-term follow-up on survival
时间窗: 3 years
Long-term follow-up on disease status
时间窗: 3 years
Long-term follow-up on cancer-related treatments
时间窗: 3 years
次要结局
未报告次要终点
