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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001449-13-HU

Enrollment

Registered

2004-08-25

Start date

2004-08-03

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Non-Hodgkin-Lymphoma receiving chemotherapy and developing Neutropenia due to chemotherapy.

Interventions

Product Name: (r-metHuG-CSF) Product Code: XM02 Pharmaceutical Form: Solution for injection CAS Number: 121181-53-1 Current Sponsor code: XM02 Other descriptive name: (r-metHuG-CSF) Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

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) =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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: Incidence of adverse events Changes of safety laboratory parameters Immunogenicity (development of antibodies against study drug).	—

Measure

Time frame

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: Incidence of adverse events Changes of safety laboratory parameters Immunogenicity (development of antibodies against study drug).

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Countries

Hungary, Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026