EUCTR2004-001449-13-LT进行中（未招募）不适用
Safety and Efficacy of XM 02 in patients with Non-Hodgkin-Lymphoma receiving chemotherapy.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
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 of any ethnic origin with aggressive Non-Hodgkin-Lymphoma meeting all criteria listed will be eligible for participation in the trial.
- •- Signed and dated written informed consent
- •- Men and women aged more then 18 years
- •- Aggressive Non-Hodgkin-Lymphoma, defined as diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, follicular lymphoma grade 3-4, or anaplastic large cell lymphoma.
- •- Patients planed/eligible to recece CHOP regimen as routine chemotherapy for their Non-Hodgkin´s lymphoma requiring G-CSF support in the investigator´s opinion
- •- Life-expectancy of at least 6 month as judged by investigator
- •- Chemotherapy naive
- •- Adeququate cardiac function as assessed by the investigator
- •- Alanine and aspartate aminotransferases (ALT/AST) <3 x upper limit of normal (ULN), bilirubin <2 x ULN
- •- Creatinine <2 x ULN
- •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
- •- Participation in a clinical trial within 30 days before randomisation
- •- Lymphoblastic lymphoma, Burkitt's lymphoma, transformed lymphoma, CNS-lymphoma
- •- Previous exposure to Filgrastim, Pegfilgrastim or Lenograstim
- •- Underlying neuropathy of grade 2 or higher
- •- Treatment with systemically active antibiotics within 72 hours before chemotherapy
- •- Treatment with lithium
- •- Chronic use of oral corticosteroids
- •- Prior radiation therapy within 4 weeks before randomisation
- •- Prior bone marrow or stem cell transplantation
- •- Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint -
- •- Pregnant or nursing women are excluded
- •- Women of child-bearing potential must agree to use a chemical or barrier contraceptive during the treatment period.
- •- Human immunodeficiency virus (HIV) infection, positive for hepatitis B surface antigen and/or hepatitis C virus
研究者
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