treatment for subjects with non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: 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.


Eligibility criteria:
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

Keywords: non-hodgkin's lymphoma r-chop-14 pegfilgrastim neutropenia, clinical trial haematopoietic growth factor