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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02782845

Enrollment

Registered

2016-05-25

Start date

2006-06-30

Completion date

2007-10-31

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

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.

Interventions

DRUGPegfilgrastim

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.

DRUGChemotherapy

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

DRUGImmunochemotherapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Colombia, Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026