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

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