Trial information
An Expanded Access Program of Neulastim (Pegfilgrastim)in Patients With Non-Hodgkin's Lymphoma
Status: Completed
Protocol number: ML19812
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: An expanded access program to evaluate the effect of Neulastim on the incidence of neutropenia-related effects in patients receiving first or second line treatment for non-Hodgkin´s lymphoma.
Brief summary: This study will assess the prophylactic effect of Neulastim on febrile and/or grade IV neutropenia in patients receiving chemotherapy or immunochemotherapy as first or second line treatment for non-Hodgkin's lymphoma. Neulastim will be administered at a fixed dose of 6mg sc 24 hours after the end of each treatment cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 120.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Non-Hodgkin's Lymphoma
Intervention type: Drug
Intervention name: pegfilgrastim[Neulastim]
Primary outcome: 1. Incidence of febrile and/or grade IV neutropenia in cycle 1 of chemotherapy or immunochemotherapy
Key secondary outcomes: 1. Efficacy:Incidence of febrile and/or severe neutropenia in cycles 2-6 of treatment. Safety:AEs, laboratory tests
Inclusion criteria:
- adult patients, 18-65 years of age;
- non-Hodgkin's lymphoma;
- ECOG 0-2.
Exclusion criteria:
- any premalignant myeloid condition;
- bone marrow involvement;
- hypersensitivity reactions to other E. coli products;
- active infections requiring the use of systemic ant-infective therapies.
Gender: Males or Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/16/2006
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Colombia
Mexico
- Chihuahua
- Guadalajara
- Huixquilucan
- Leon
- Mexico City
- Obregon
- Puebla
- Tepic
