Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Spectrum Pharmaceuticals, Inc
With
CTI BioPharma
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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.
Clareo Health | Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)
