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

Follicular Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00384111
• Other study ID #: 106NH301
• Status: Terminated
• Phase: Phase 3
• Start date: October 2006
• Est. completion date: November 2008

Study information

• Verified date: December 2021
• Source: Spectrum Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin

Intervention

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
• R-CVP
Standard R-CVP

Locations

Country	Name	City	State
United States	Chattanooga Oncology Hematology Care	Chattanooga	Tennessee
United States	Oncology Hematology Care Inc.	Cincinnati	Ohio
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	Wellstar-Northwest Georgia Oncology Centers	Marietta	Georgia
United States	Tennessee Oncology	Nashville	Tennessee
United States	Gulfcoast Oncology Associates	Saint Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Pharmaceuticals, Inc	CTI BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events		18 months
Secondary	Number of Participants With Serious and Non-serious Adverse Events		18 months