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临床试验/NCT00066092
NCT00066092已完成2 期

Randomized, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Hodgkin's or Non-Hodgkin's Lymphoma.

Amgen0 个研究点目标入组 41 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Amgen
入组人数
41
主要终点
CD34+ collection during the collection phase

研究概览

简要总结

This is a randomized, double-blind, multi-center study to assess the safety and effectiveness of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.

详细描述

This is a research study for Hodgkin's Disease and Non-Hodgkin's Lymphoma (NHL) patients who will receive high-dose chemotherapy with autologous peripheral blood stem cell (PBSC or PBPC) transplant. The chemotherapy doses are high enough to severely suppress the bone marrow (where blood cells are made) and cause very low blood counts. A collection of stem cells (very young blood cells) followed by reinfusion to restore blood counts will be done to stimulate recovery of your blood counts. This procedure is called leukapheresis. Giving growth factors to patients is a method to increase the number of PBPC that can be collected during leukapheresis. This process of giving growth factors to patients is called mobilization (moving cells from the bone marrow to the peripheral blood where they can be collected). The purpose of this study is to determine if pegfilgrastim, an investigational drug, can safely and effectively mobilize stem cells. Filgrastim (also known as NEUPOGEN® or G-CSF) is approved by the FDA for stem cell mobilization. Pegfilgrastim is a modified version of Filgrastim that is longer acting.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Pegfilgrastim 6 mg

Experimental

Pegfilgrastim 6 mg given once for PBPC mobilization

干预措施: pegfilgrastim 6 mg (Drug)

Pegfilgrastim 12 mg

Experimental

Pegfilgrastim 12 mg given once for PBPC mobilization

干预措施: pegfilgrastim 12 mg (Drug)

filgrastim

Active Comparator

Filgrastim given daily for PBPC mobilization

干预措施: filgrastim (Drug)

结局指标

主要结局

CD34+ collection during the collection phase

时间窗: 10 days

次要结局

  • Time to ANC and platelet engraftment post-transplant(100 days)

研究者

发起方
Amgen
申办方类型
Industry

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