临床试验/NCT01828619

NCT01828619Unknown不适用

The Study of New RIC Regimen of BuFlu in Older or Intolerable Patients With Hematologic Malignant Diseases

Peking University People's Hospital1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2013年2月最近更新: 2013年4月10日

适应症

试验速览

阶段: 不适用
发起方: Peking University People's Hospital
入组人数: 60
试验地点: 1
主要终点: stem cell engraftment

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 determine whether the new RIC regimen, containing of low dose of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem cell transplantation.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

年龄范围: 55 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•diagnosed of hematologic malignant disease
•will undergo HLA matced HSCT
•age >=55years
•<55year and intolerable to standard myeloablative conditioning

排除标准

•KPS status <70
•cardiac EF<50%
•creatine clearance <50 ml/min
•ALT more than 10 times of upper normal limit

结局指标

主要结局

stem cell engraftment

时间窗: 30day post transplantation

次要结局

toxicity and treatment related mortality(100day and 1 year post transplantation)

研究者

发起方

Peking University People's Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

FENGRONG WANG

Department of Hematology

Peking University People's Hospital

研究点 (1)

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