Status:
TERMINATED
Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Collaborating Sponsors:
CTI BioPharma
Conditions:
Follicular Lymphoma
Lymphoma, Follicular
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00384111
Start Date
October 1 2006
End Date
November 1 2008
Last Update
January 14 2022
Active Locations (6)
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1
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
2
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States, 33705
3
Wellstar-Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
4
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States, 45242