Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)

A Phase 3 Open Label Multicenter, Randomized Study to Compare the Efficacy and Safety of the Zevalin (Ibritumomab Tiuxetan) Therapeutic Regimen Following Cyclophosphamide, Vincristine, Prednisone, and Rituximab (R-CVP) With R-CVP Alone in High-Risk Subjects With Previously Untreated CD20-Positive Follicular Non-Hodgkin's Lymphoma

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.

Study Overview

• Status: Terminated
• Conditions: Lymphoma, Follicular; Follicular Lymphoma
• Intervention / Treatment: Drug: Zevalin Therapeutic Regimen; Drug: R-CVP

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Integrated Community Oncology Network
    • Saint Petersburg, Florida, United States, 33705
      • Gulfcoast Oncology Associates
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Wellstar-Northwest Georgia Oncology Centers
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Oncology Hematology Care Inc.
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Oncology Hematology Care
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Participants will receive standard R-CVP followed by Zevalin Therapeutic Regimen (Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin).	Drug: Zevalin Therapeutic Regimen; Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin; Drug: R-CVP; Standard R-CVP
Active Comparator: 2; Participants will receive standard R-CVP.	Drug: R-CVP; Standard R-CVP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Serious and Non-serious Adverse Events	18 months

Collaborators and Investigators

• Sponsor: Spectrum Pharmaceuticals, Inc
• Collaborators: CTI BioPharma

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2006
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: October 3, 2006
• First Submitted That Met QC Criteria: October 3, 2006
• First Posted (Estimate): October 5, 2006

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: 106NH301