Safety and Efficacy of XM 02 in patients with Non-Hodgkin-Lymphoma receiving chemotherapy.

BioGeneriX AG0 个研究点目标入组 90 人开始时间: 2004年10月28日最近更新: 2012年3月19日

试验速览

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•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

•- 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

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