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Sponsored by: |
Amgen |
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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 - Life expectancy greater than or equal to 12 weeks - Absolute neutrophil count greater than 1.5 x 109/L - Platelet count greater than 100 x 109/L - Adequate organ function (serum creatinine less than or equal to 2.0 mg/dL, SGOT/AST and SGPT/ALT less than 3 x the upper limit of normal, hemoglobin greater than or equal to 10g/dL and total serum bilirubin less than or equal to 1.5 mg/dL) - Left Ventricular Ejection Fraction (LVEF) greater than or equal to 50% at rest by MUGA or echocardiogram - Previously untreated with chemotherapy or radiotherapy - Before any study specific procedure or before study medication was administered, the subject was to give written informed consent for participation in the study Exclusion Criteria: - Burkitt's or B-lymphoblastic lymphoma - CNS involvement - Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, antiviral) within 72 hours of chemotherapy - Use of anti-hypertensives within 12 hours of start of chemotherapy - Known HIV infection - Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukaemia) - Prior malignancy within the last 5 years, with the exception of surgically cured basal cell carcinoma, squamous skin cell carcinoma, or in situ carcinoma of the cervix - Prior bone marrow or stem cell transplantation - History of impaired cardiac status, e.g. severe heart disease,cardiomyopathy, or congestive heart failure - Major surgery within 2 weeks prior to randomization - Subject is evidently pregnant (e.g., positive HCG test unless termination is proven) or is breast feeding - Subject is not using adequate contraceptive precautions - Known hypersensitivity to E coli-derived products (e.g., Filgrastim,HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®) - Any psychiatric, addictive or other kind of disorder which compromised the ability of the subject to give written informed consent and/or to comply with study protocol procedures - Prior exposure to pegfilgrastim - Subject is currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s) - Subject has previously entered this study
Austria | |
Research Site | |
Wien, Austria | |
Research Site | |
Linz, Austria | |
France | |
Research Site | |
Le Chesnay, France | |
Research Site | |
Besançon Cedex, 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 (Barcelona), Spain |
Study Director: | MD | Amgen |
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20010157 |
Study First Received: | June 30, 2005 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00117897 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
non-Hodgkin's lymphoma R-CHOP-14 pegfilgrastim neutropenia, clinical trial haematopoietic growth factor |
Lymphatic Diseases Neutropenia Immunoproliferative Disorders Rituximab |
Lymphoma, small cleaved-cell, diffuse Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |