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

Phase 4

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: Chemotherapy; Drug: Immunochemotherapy; Drug: Pegfilgrastim

• Registration Number: NCT02782845
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-24
• Study First Posted: 2016-05-25
• Status Verified: 2016-09
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pegfilgrastim	Pegfilgrastim	Participants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care.
Pegfilgrastim	Chemotherapy	Participants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care.
Pegfilgrastim	Immunochemotherapy	Participants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Febrile Neutropenia (Absolute Neutrophil Count [ANC] <0.5x10^9/L and Temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycle 1	Cycle 1 (Up to 21 days)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Febrile Neutropenia (ANC <0.5x10^9/L and temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycles 2 to 6	Cycles 2 to 6 (Up to 105 days)
Percentage of Participants with Adverse Events	up to approximately 1.5 years