NCT02782845

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

Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Chemotherapy	The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.
DRUG	Immunochemotherapy	The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug.
DRUG	Pegfilgrastim	Pegfilgrastim will be administered at a fixed dose of 6 mg subcutaneously 24 hours after the last dose of CT or ICT is received for 6 cycles.

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2016-05-25
• Last updated: 2016-11-21

Locations

19 sites across 2 countries: Colombia, Mexico