A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 99,999
- 试验地点
- 255
- 主要终点
- Neutrophil recovery of ≥500/mm3 after cord blood transplantation
研究概览
简要总结
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
详细描述
Principal Investigators:
The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.
Study Design:
This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
Primary Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
- •Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
- •Pediatric and adult patients of any age
排除标准
- •Patients who are receiving only licensed CBUs
- •Cord blood transplant recipients at international transplant centers
- •Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
- •Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
研究组 & 干预措施
Unlicensed CBU
The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
干预措施: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) (Drug)
结局指标
主要结局
Neutrophil recovery of ≥500/mm3 after cord blood transplantation
时间窗: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.
The primary objective of this access and distribution protocol is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.
Neutrophil recovery of ≥500/mm3 after cord blood transplantation
时间窗: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.
The primary objective of this access and distribution protocol is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.
次要结局
未报告次要终点