Follicular Lymphoma, Lymphoma, Follicular
Conditions
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.
Interventions
DRUGZevalin 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
DRUGR-CVP
Standard R-CVP
Sponsors
CTI BioPharma
Spectrum Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Serious and Non-serious Adverse Events | 18 months |
Countries
United States
Participant flow
Pre-assignment details
It was planned to randomized the enrolled subjects to receive R-CVP followed by Zevalin Therapeutic Regimen or R-CVP. However, due to low enrollment and early termination, participants were not randomized and received any treatment. The data for the Participant flow and Baseline sections is reported for all enrolled participants in one arm.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Disease Progression | 3 |
| Overall Study | Investigator Decision | 3 |
| Overall Study | Study Terminated by the Sponsor | 19 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants With Adverse Events
Time frame: 18 months
Population: Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor.
Secondary
Number of Participants With Serious and Non-serious Adverse Events
Time frame: 18 months
Population: Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor.