跳至主要内容
临床试验/NCT05290662
NCT05290662招募中不适用

A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have Received oNKord®

Glycostem Therapeutics BV2 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2022年6月14日最近更新:
适应症
干预措施
相关药物

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

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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