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

Roche

Status and phase: Completed; Phase 4

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Chemotherapy; Drug: Pegfilgrastim; Drug: Immunochemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02782845

ML19812

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Pegfilgrastim

Experimental group

Description:

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.

Treatment:

Drug: Pegfilgrastim

Drug: Immunochemotherapy

Drug: Chemotherapy