扩大 Omidubicel 的使用范围，用于血液系统恶性肿瘤患者的同种异体移植
2026年5月24日 更新者：Gamida Cell ltd
Omidubicel 的开放标签扩展访问研究，用于血液系统恶性肿瘤患者的同种异体移植
Omidubicel 是一种针对高危血液系统恶性肿瘤患者的研究性疗法。
研究概览
详细说明
成功的血液和骨髓移植 (BMT) 需要输注足够数量的造血干细胞/祖细胞 (HSPC)，这些细胞能够归巢到骨髓并再生具有早期和晚期重新增殖能力的全套造血细胞谱系及时时尚。
Omidubicel 是一种基于干细胞/祖细胞的产品，由来自一整单位脐带血的体外扩增的同种异体细胞组成。 Omidubicel 利用小分子烟酰胺 (NAM) 作为一种表观遗传学方法来抑制分化并增加在离体培养物中扩增的造血祖细胞 (HPC) 的迁移、骨髓 (BM) 归巢和植入效率。
总体研究目标是为血液恶性肿瘤患者提供用于移植的奥米比塞，并收集额外的安全性和有效性数据。
研究类型
介入性
注册 (实际的)
36
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
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Los Angeles、California、美国、90095
- UCLA
-
Palo Alto、California、美国、94063
- Stanford University Cancer Institute
-
-
Illinois
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Maywood、Illinois、美国、60153
- Loyola University, Cardinal Bernardin Cancer Center
-
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Minnesota
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Minneapolis、Minnesota、美国、55455
- University of Minnesota Masonic Cancer Center
-
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health & Science University
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
12年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 患者必须年满 12 岁
- 适用疾病标准
- 患者必须有一个或两个 HLA 部分匹配的 CBU
- 备用干细胞来源
- 充足的生理储备
- 有生育能力的女性同意使用适当的避孕方法
- 签署书面知情同意书
排除标准：
- 广泛的骨髓纤维化
- 供体特异性抗 HLA 抗体
- 怀孕
- 医学上不适合移植
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：omidubicel
Received omidubicel
|
造血干细胞移植
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time From Transplant to Neutrophil Engraftment
大体时间：by day 42 post-transplant inclusive
|
Neutrophil engraftment was defined as achieving an absolute neutrophil count (ANC) greater than or equal to 0.5 x 10^9/L on 3 consecutive measurements by Day 42 post-transplant inclusive.
The first day of the three measurements was designated the day of neutrophil engraftment.
|
by day 42 post-transplant inclusive
|
|
Cumulative Incidence of Neutrophil Engraftment
大体时间：by day 42 post-transplant inclusive
|
Death, second transplant, and relapse were competing risks at the time they occur if they occur prior to neutrophil engraftment, and no transplant was a competing risk at Day 0. If the patient failed to achieve neutrophil engraftment, they were considered to have a competing risk at Day 43.
|
by day 42 post-transplant inclusive
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cumulative Incidence of Platelet Engraftment >20,000 Cells/uL
大体时间：By Day 42 and Day 180 post-transplant
|
By Day 42 and Day 180 post-transplant
|
|
|
Time to Platelet Engraftment >20,000 Cells/uL
大体时间：By Day 730 post-transplant
|
Time to platelet engraftment >20,000 cells/ul was defined as the number of days from transplant to the first day of a minimum of 3 consecutive measurements on different days in which the platelet count is 20,000 cells/ul or higher with no platelet transfusion within the previous 7 days (count day of engraftment as one of the preceding 7 days) was calculated.
The first day of the three measurements was designated the day of platelet engraftment.
|
By Day 730 post-transplant
|
|
Cumulative Incidence of Platelet Engraftment >50,000 Cells/uL
大体时间：By Day 42 and Day 180 post-transplant
|
By Day 42 and Day 180 post-transplant
|
|
|
Time to Platelet Engraftment >50,000 Cells/uL
大体时间：By Day 730 post-transplant
|
Time to platelet engraftment >50,000 cells/ul was defined as the number of days from transplant to the first day of a minimum of 3 consecutive measurements on different days in which the platelet count is 50,000 cells/ul or higher with no platelet transfusion within the previous 7 days (count day of engraftment as one of the preceding 7 days) was calculated.
The first day of the three measurements was designated the day of platelet engraftment.
|
By Day 730 post-transplant
|
|
Non-relapse Mortality
大体时间：By Day 180, Day 365 and Day 730 post-transplant
|
Non-relapse mortality was defined as any death not preceded by relapse.
|
By Day 180, Day 365 and Day 730 post-transplant
|
|
Overall Survival (OS)
大体时间：By Day 180, Day 365 and Day 730 post-transplant
|
OS probability was defined as the probability of participants remaining alive at specified time points following transplantation, estimated using Kaplan-Meier methods.
|
By Day 180, Day 365 and Day 730 post-transplant
|
|
Disease Free Survival (DFS)
大体时间：By Day 365 and Day 730 post-transplant
|
Disease-free survival was defined as the survival without disease relapse or death from any cause, whichever came first.
|
By Day 365 and Day 730 post-transplant
|
|
Donor Chimerism
大体时间：By day 100 and Day 730 post-transplant
|
Patients considered to have donor chimerism when they had at least 95% donor chimerism
|
By day 100 and Day 730 post-transplant
|
|
Secondary Graft Failure (SGF)
大体时间：By Day 730 post-transplant
|
By Day 730 post-transplant
|
|
|
Disease Relapse
大体时间：By Day 365 and Day 730 post-transplant
|
By Day 365 and Day 730 post-transplant
|
|
|
Cumulative Incidence of Acute GvHD Grade II-IV
大体时间：By Day 100 post-transplant
|
Death, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events.
|
By Day 100 post-transplant
|
|
Cumulative Incidence of aGvHD Grade III-IV
大体时间：By Day 100 post-transplant
|
Death, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events.
|
By Day 100 post-transplant
|
|
Cumulative Incidence of Chronic GvHD
大体时间：By Day 180 and Day 730 post-transplant
|
Death, failure to achieve neutrophil engraftment, secondary graft failure, and relapse were considered competing events.
|
By Day 180 and Day 730 post-transplant
|
|
Chronic GvHD-free Relapse-free Survival (cGRFS)
大体时间：By Day 365 and Day 730 post-transplant
|
Chronic graft versus host disease-free, relapse-free survival (cGRFS) was defined as chronic GvHD, relapse, or death by any cause.
|
By Day 365 and Day 730 post-transplant
|
|
GvHD-free Relapse-free Survival (GRFS)
大体时间：By Day 365 and Day 730 post-transplant
|
Graft versus host disease-free, relapse-free survival (GRFS) was defined as acute GvHD Grade III-IV, chronic GvHD, relapse, or death by any cause
|
By Day 365 and Day 730 post-transplant
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mitchell Horwitz, MD、Duke University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年7月8日
初级完成 (实际的)
2025年5月8日
研究完成 (实际的)
2025年5月8日
研究注册日期
首次提交
2020年2月5日
首先提交符合 QC 标准的
2020年2月5日
首次发布 (实际的)
2020年2月7日
研究记录更新
最后更新发布 (实际的)
2026年6月22日
上次提交的符合 QC 标准的更新
2026年5月24日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.