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

NCT ID: NCT00384111

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-11-30

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. 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.

Conditions

Follicular Lymphoma; Lymphoma, Follicular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Zevalin Therapeutic Regimen

Intervention Type: DRUG

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

R-CVP

Intervention Type: DRUG

Standard R-CVP

2

Participants will receive standard R-CVP.

Group Type: ACTIVE_COMPARATOR

R-CVP

Intervention Type: DRUG

Standard R-CVP

Interventions

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

Intervention Type: DRUG

R-CVP

Standard R-CVP

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CTI BioPharma

INDUSTRY

Sponsor Role: collaborator

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Integrated Community Oncology Network

Jacksonville, Florida, United States

Gulfcoast Oncology Associates

St. Petersburg, Florida, United States

Wellstar-Northwest Georgia Oncology Centers

Marietta, Georgia, United States

Oncology Hematology Care Inc.

Cincinnati, Ohio, United States

Chattanooga Oncology Hematology Care

Chattanooga, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

106NH301

Identifier Type: -

Identifier Source: org_study_id