临床试验/NCT00202917

NCT00202917已完成1 期

Multicenter Phase I/II Study of Haploidentical Hematopoietic Cell Transplantation With CD3/CD19 Depleted Grafts in Patients With Treatment Refractory Hematologic Malignancies

University Hospital Tuebingen7 个研究点分布在 1 个国家目标入组 61 人开始时间: 2004年2月1日最近更新: 2014年5月29日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: University Hospital Tuebingen
入组人数: 61
试验地点: 7
主要终点: Mortality and Morbidity

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

The purpose of this study is to study the feasibility and Toxicity of allogeneic haploidentical hematopoietic cell transplantation with CD3/CD19 depleted stem cells and a dose reduced conditioning.

详细描述

Transplantation of a CD3/CD19 depleted stem cell grafts after dose reduced conditioning for the treatment of treatment refractory or relapsed hematologic malignancies after preceding allogeneic or autologous hematopoietic cell transplantation.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age <60, >18 years
•Karnofsky >60%
•High risk hematologic malignancy or relapse after preceding auto/allo HCT in patients with:
•MDS (RAEB-t/secondary AML)
•No HLA-identical MRD or URD if not preceding allo-HCT
•Use haploidentical donor with KIR-Mismatch if choice

排除标准

•< 3 months after preceding HCT
•Active cerebral seizures
•> 30% blasts in BM if ALL/AML/CML-BC
•Completely chemo-refractory
•Preceding myocardial infarction
•Ejection fraction <30 % echocardiography
•Creatinine clearance <50 ml/min
•Respiratory insufficiency on supplemental O2 or DLCO < 30%
•Allergy against murine antibodies
•HIV infection
•Pregnancy
•Unable for informed consent

结局指标

主要结局

Mortality and Morbidity

Toxicity

Engraftment

次要结局

GVHD
Immune reconstitution
Infections
Disease response
Long term toxicity

研究者

发起方

University Hospital Tuebingen

申办方类型

Other

研究点 (7)

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