phase 3 study of zevalin following r-cvp in previously untreated patients with follicular non hodgkin's lymphoma (nhl)

Conditions: Follicular Lymphoma; Lymphoma, Follicular

Summary: this study will treat follicular lymphoma patients who have not received previous treatment with r-cvp. half of the patients will receive zevalin after r-cvp and the other half will receive only r-cvp. the two patient groups will be compared to determine if zevalin given after r-cvp therapy provides greater benefits than receiving no additional anti-cancer therapy after r-cvp.


Eligibility criteria:
inclusion criteria: * must give written informed consent and any authorizations required by local law (e.g., protected health information). * age greater than or equal to 18 years at the time of informed consent. * histologically confirmed follicular nhl according to the revised european american lymphoma (real)/world health organization (who)classification (from initial diagnosis); grades 1, 2, or 3. * bi-dimensionally measurable lesion(s) in at least one site. * high risk nhl as defined by a follicular lymphoma international prognostic index (flipi) of 3, 4, or 5 assessed within 3 months prior to randomization. * nhl requires treatment as determined by the investigator. * confirmed cd20+ lymphoma cells. * eastern cooperative oncology group (ecog) performance status of 0, 1,or 2. * expected survival of greater than or equal to 3 months. * male subjects and female subjects of child bearing potential willing to practice effective contraception during the study and willing and able to continue contraception for 1 year after their last dose of study treatment (r cvp for subjects in the observation arm and the zevalin therapeutic regimen for subjects in the zevalin arm). exclusion criteria: * previous anticancer treatment for nhl, including chemotherapy, immunotherapy, radiation (locoregional or extended field), radioimmunotherapy, or investigational therapy. * known seropositivity for hepatitis c virus, hepatitis b virus (surface antigen-positive), or other active infection uncontrolled by treatment. * known diagnosis of human immunodeficiency virus infection. * presence of primary gastric, central nervous system (cns), or testicular lymphoma, or transformed lymphoma, or chronic lymphocytic leukemia (cll). * active therapy within previous 5 years for other malignancy, except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * abnormal liver function: total bilirubin \>1.5 x upper limit of normal (uln) or alt \>2.5 x uln. * impairment of renal function (serum creatinine \>1.5 x uln) not due to lymphoma. * concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) that could compromise participation in the study. * known hypersensitivity to murine and/or chimeric proteins. * history of severe allergic or anaphylactic reactions. * known allergy to any components present in rituximab, cyclophosphamide, vincristine, and prednisone (cvp), or zevalin. * treatment with another study treatment or approved therapy for investigational use within the 12 weeks prior to randomization. * exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins. * females with a positive pregnancy test result at screening or who are currently breastfeeding. * inability to comply with study requirements. * major surgery within 28 days except for diagnosis. * in need of immediate intervention to treat life threatening complications.