Skip to main content
OpenTrials
Completed

NCT Number: NCT02782845

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bogotá, Colombia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

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

Immunochemotherapy

Drug

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

pegfilgrastim

Drug

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.

Other names: Neulastim

Primary outcomes

  1. 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

  1. 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)

  2. Percentage of Participants with Adverse Events

    Time frame: up to approximately 1.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 25, 2016
Registry last updated
Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.