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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstration of safety of XM 02 when administered for up to a maximum of six cycles in patients with Non-Hodgkin-Lymphoma receiving CHOP chemotherapy. ;Secondary Objective: Demonstration of efficacy of XM 02 (in the first cycle compared to Filgrastim) in patients with Non-Hodgkin-Lymphoma. Evaluation of pharmacokinetic properties of XM 02 in comparison to Filgrastim.;Primary end point(s): Safety: <br>Incidence of adverse events<br>Changes of safety laboratory parameters<br>Immunogenicity (development of antibodies against study drug). <br>

Secondary Outcome Measures

Name	Time	Method

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