Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Amgen |
---|---|
Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00117897 |
This multicenter, open-label, randomized, parallel study was designed to evaluate whether a single fixed-dose subcutaneous (SC) administration of pegfilgrastim or daily administration of Filgrastim for absolute neutrophil count (ANC) support would assist in allowing the planned dose-on-time (PDOT) of cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) chemotherapy with Rituximab every 14 days in subjects with aggressive B-cell Non-Hodgkin's Lymphoma by reducing the duration of neutropenia and incidence of febrile neutropenia.
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin's Lymphoma |
Drug: pegfilgrastim Drug: Filgrastim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | An Open-Label, Randomized, Parallel, Phase II Study of CHOP Chemotherapy and Rituximab Administered Every 14 Days, With Pegfilgrastim or Filgrastim Support, for the Treatment of Subjects With Non-Hodgkin's Lymphoma |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | February 2004 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Histologically proven aggressive B-cell Non-Hodgkin's lymphoma (IWF classification D-H) with: - Bone marrow involvement less than 30% demonstrated by aspiration - Age-adjusted International Prognostic Index (IPI) 0-2 - Measurable or evaluable disease - ECOG performance status 0-2
Austria | |
Research Site | |
Wien, Austria | |
Research Site | |
Linz, Austria | |
France | |
Research Site | |
Le Chesnay, France | |
Research Site | |
Besançon, France | |
Spain | |
Research Site | |
Barcelona, Spain | |
Research Site | |
Badalona, Spain | |
Research Site | |
Murcia, Spain | |
Research Site | |
Salamanca, Spain | |
Research Site | |
Madrid, Spain | |
Research Site | |
Santander, Spain | |
Research Site | |
L'Hospitalet de Llobregat, Spain |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010157 |
Study First Received: | June 30, 2005 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00117897 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
non-Hodgkin's lymphoma R-CHOP-14 pegfilgrastim neutropenia, clinical trial haematopoietic growth factor |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Neutropenia Immunoproliferative Disorders Rituximab |
Mitogens Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |