临床试验/NCT00410696

NCT00410696已完成2 期

Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial

Armando Santoro, MD1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2006年9月最近更新: 2013年7月1日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 80
试验地点: 1
主要终点: Duration of aplasia period

研究概览研究设计入排标准研究组 & 干预措施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 primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.

详细描述

Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

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

入选标准

•Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
•Adequate organ function
•Written informed consent.

排除标准

•Use of other experimental drugs
•Active infection

研究组 & 干预措施

Filgrastim

Active Comparator

Filgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days)

干预措施: Filgrastim (Drug)

Pegfilgrastim

Experimental

Pegfilgrastim administered the day after autologous stem-cell reinfusion

干预措施: Pegfilgrastim (Drug)

结局指标

主要结局

Duration of aplasia period

时间窗: At time of discharge from Unit

次要结局

Immunological reconstitution(1 year after transplantation)

研究者

发起方

Armando Santoro, MD

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Armando Santoro, MD

Istituto Clinico Humanitas

研究点 (1)

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