NCT02162511已完成不适用
An Expanded Access Study Using the CliniMACS System to Offer Therapeutic Manipulated Grafts That Are CD34 Cell Enriched and T Cell Depleted for Allogeneic Stem Cell Recipients With Mismatched Related Donors or Borderline Organ Function
Rajni Agarwal1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2014年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Patients With Severe (Grade III/IV) Acute Graft vs Host Disease (GVHD)
研究概览
简要总结
The purpose of this protocol is to provide access to the CliniMACS® System to hematopoietic cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS system is currently approved for use in patients who have AML, and a genetically matched sibling donor. Through this protocol, the investigators will be able to offer potentially life-saving transplants to patients who have genetically mis-matched donor, who have no other options for treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant age is 0 (newborn) to 35 years-old.
- •Participant has a disorder affecting the hematopoietic system that are inherited, acquired, or a result from the myeloablative treatment that can benefit from alternative stem cell transplantation according to standard practice guidelines for including patients for transplant.
- •Participant's medical screening clears s/he for allogeneic transplantation as per current institutional SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation (FACT);
- •Participant must lack a healthy, HLA-identical related or unrelated donor unless s/he has a borderline organ function that will preclude the recipient from receiving a curative therapy due to the need of post-HSCT immunosuppressive therapy.
- •Participant must have a matched or mismatched-related donor who is:
- •Able to receive granulocyte colony-stimulating factor (G-CSF) and undergo apheresis either through placement of catheters in antecubital veins or a temporary central venous catheter OR agrees on a bone marrow harvest;
- •Healthy as per donor selection screening (following current SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation - FACT);
- •Willing to participate and sign consent.
- •Participant or Legal Authorized Representative is able to sign informed consent (and signed assent, if applicable) for transplant.
排除标准
- •Participant does not qualify for an allogeneic transplant due to medical screening, underlying disease, or lack of alternative donors.
- •Any condition that compromises compliance with the procedures of this protocol, as judged by the principal investigator.
研究组 & 干预措施
ARM B Malignant Non-TBI
Experimental
Malignant diseases chemotherapy based conditioning
干预措施: CliniMACS CD34+ cell enrichment and T-cell depletion (Device)
ARM C Non-malignant
Experimental
Non-malignant diseases Chemotherapy based conditioning
干预措施: CliniMACS CD34+ cell enrichment and T-cell depletion (Device)
ARM A Malignant TBI
Experimental
Malignant diseases Conditioning including total body irradiation and chemotherapy
干预措施: CliniMACS CD34+ cell enrichment and T-cell depletion (Device)
结局指标
主要结局
Number of Patients With Severe (Grade III/IV) Acute Graft vs Host Disease (GVHD)
时间窗: Day +100
GVHD is a condition that occurs when donor bone marrow or stem cells attack the recipient.
次要结局
- Length of Time to Engraftment(up to +1 year post-transplant)
- Number of Participants With Graft Failure(Up to Day +42 after stem cell transplant)
- Immune Recovery (CD4)(up to +1 year post-transplant)
- Immune Recovery Shown as Phytohemagglutin (PHA)(6 months and 1 year post-transplant)
- Number of Patients With Post-transplant Lymphoproliferative Disease (PTLD)(up to +1 year post-transplant)
- Transplant-related Mortality (TRM)(at Day +100 and +1 year post-transplant)
- Number of Participants Experiencing Post-transplant Infections(up to +1 year post-transplant)
- Chimerism of Donor Cells(Day +100 post-transplant)
- Number of Participants With Immune Recovery (CD4 >200) by Year 1(up to +1 year post-transplant)
- Number of Patients With Severe Toxicities(up to +1 year post-transplant)
研究者
Rajni Agarwal
Principal Investigator
Stanford University
研究点 (1)
Loading locations...
相似试验
No Longer Available
不适用
CliniMACS® CD34+ Reagent System for Expanded Access UseAnemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem CellsGraft-Versus-Host Disease(GVHD)Graft FailureDelayed Graft FunctionNCT02026934Joseph Antin
Available
不适用
Expanded Access Protocol Using Alpha/Beta T and CD19+ Depleted PBSCBone Marrow Failure SyndromeImmunodeficienciesLeukemiaNCT03145545Children's Hospital of Philadelphia
招募中
早期 1 期
Expanded Access Protocol Using CD3+/CD19+ Depleted PBSCImmunodeficienciesInborn Errors of MetabolismImmunodysregulation Polyendocrinopathy Enteropathy X-linked SyndromeBone Marrow Failure SyndromesLeukemiaNCT02356653Children's Hospital of Philadelphia100
已完成
2 期
HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic MalignanciesAcute Myelogenous LeukemiaMultiple MyelomaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromeNCT01119066Memorial Sloan Kettering Cancer Center422
No Longer Available
不适用
Expanded Access Multicenter Study of Lucanix® (Belagenpumatucel-L)Non-small Cell Lung CancerNCT01279798NovaRx Corporation