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

Hoffmann-La Roche53 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Hodgkin's Lymphoma

Interventions

ChemotherapyDRUG

The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.

ImmunochemotherapyDRUG

The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug.

PegfilgrastimDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (19)

Unnamed facility

Bogotá, Colombia

Unnamed facility

Chihuahua City, Mexico

Unnamed facility

Chihuahua City, Mexico

Outcomes

Primary Outcomes

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

Time frame: Cycle 1 (Up to 21 days)

Secondary Outcomes

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

Time frame: Cycles 2 to 6 (Up to 105 days)

Percentage of Participants with Adverse Events

Time frame: up to approximately 1.5 years

Data from ClinicalTrials.gov

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