An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each treatment cycle.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• NHL supported by an Immunohistochemical report

• Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to (>/=) 2

• Total serum bilirubin less than (<) 2 times upper limit of normal (ULN)

• Absolute neutrophil count (ANC) greater than (>) 2 x10^9 per liter (/L)

Exclusion Criteria:

• Bone marrow compromised > 10 percent (%)

• Any malignant myeloid condition

• Active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to CT or ICT initiation

• Known hypersensitivity reactions to Escherichia coli derived products

• Pregnant or nursing participants. Women with childbearing potential should use a safe contraceptive method