A comparatiVe Study on Efficacy and Safety of Lipegfilgrastim in Comparison to Pegfilgrastim in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia

Exclusion Criteria

• •1. Participation in a clinical study within 30 days before randomization
• •2. Any chemotherapy within the last 3 months before start of chemotherapy. A prephase to reduce tumor burden prior to start of R-CHOP is allowed.
• •3. The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
• •4. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy.
• •5. Active cardiac disease
• •6. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of chemotherapy.
• •7. Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C.
• •8. Patients with evidence or history of bleeding diathesis.
• •9. Non-healing wound, ulcer or bone fracture.
• •10. Renal failure requiring hemo- or peritoneal dialysis.
• •11. Any conditions that may interfere with the patient's participation in the study or evaluation of the study results.
• •12. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
• •13. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
• •14. Treatment with lithium at screening or planned during the study.
• •* Other Criteria apply, please contact the investigator for more information