临床试验/NCT00569283

NCT00569283已完成1 期

Donor Natural Killer Cell Infusion for the Prevention of Relapse or Graft Failure After HLA-Haploidentical Familial Donor Bone Marrow Transplantation-A Phase I Study

Asan Medical Center2 个研究点分布在 1 个国家目标入组 18 人开始时间: 2007年5月1日最近更新: 2013年3月26日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Asan Medical Center
入组人数: 18
试验地点: 2
主要终点: Maximum tolerated dose of donor natural killer (NK) cells

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Giving donor natural killer cells to patients who have undergone donor bone marrow transplant may make the transplant work better and keep cancer cells from coming back.

PURPOSE: This phase I trial is studying the side effects and best dose of donor natural kill cells in preventing relapse or graft failure in patients who have undergone donor bone marrow transplant.

详细描述

OBJECTIVES:

Primary

To ascertain the safety of donor natural killer (NK) cells, generated from peripheral blood hematopoietic stem cells, when given as a single intravenous infusion in patients who have undergone HLA-haploidentical familial donor bone marrow transplantation (BMT).
To determine the maximum tolerated dose of donor NK cells when given as a single infusion.

Secondary

To determine the effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor BMT.

研究设计

研究类型: Interventional
主要目的: Treatment

入排标准

年龄范围: — 至 65 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•DISEASE CHARACTERISTICS:
•Has undergone HLA-haploidentical familial donor bone marrow transplantation within the past 4-6 weeks
•No manifestations of acute graft-vs-host disease at the time of planned donor natural killer cell infusion
•PATIENT CHARACTERISTICS:
•Karnofsky performance status 70-100%
•Bilirubin < 2.0 mg/dL
•AST < 3 times upper limit of normal
•Creatinine < 2.0 mg/dL
•Ejection fraction > 40% on MUGA scan
•PRIOR CONCURRENT THERAPY:
•See Disease Characteristics

排除标准

未提供

结局指标

主要结局

Maximum tolerated dose of donor natural killer (NK) cells

Safety

Effectiveness of donor NK cell infusion in preventing tumor relapse and graft failure after HLA-haploidentical familial donor bone marrow transplantation

次要结局

未报告次要终点

研究者

发起方

Asan Medical Center

申办方类型

Other

研究点 (2)

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