EUCTR2006-003682-14-DE进行中（未招募）不适用
Randomised phase II study on the treatment with pegfilgrastim after autologous blood stem cell transplantation
GMIHO Gesellschaft für Medizinische Innovation/Hämatologie und Onkologie mbH0 个研究点开始时间: 2007年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- patients with leukemia (with exceptions, cf. exclusion criteria), lymphoma or multiple myeloma (first-line or in first relapse) after autologous peripheral blood stem cell transplantation
- •- transfused CD34+ >= 2,0*10^6/kg body weight
- •- age >= 18 years
- •- adequate contraceptive measures in case of reproductive potential (oral contraceptives, implantable or injectable contraceptive drugs, hormonal IUDs, vasectomy of the partner, or abstinence
- •- negative pregnancy test
- •- written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- hypersensitivity against pegfilgrastim, other proteins manufactured using E. coli, or one of the drugs other components
- •- patients with myelodysplastic syndrome
- •- patients with chronic myeloid leukemia
- •- patients with secondary AML
- •- pregnant or lactating women
- •- insufficient compliance anticipated
研究者
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