Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
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
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events [18 months]
Secondary Outcome Measures
- Number of Participants With Serious and Non-serious Adverse Events [18 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information).
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Age greater than or equal to 18 years at the time of informed consent.
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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.
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Bi-dimensionally measurable lesion(s) in at least one site.
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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.
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NHL requires treatment as determined by the investigator.
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Confirmed CD20+ lymphoma cells.
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Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1,or 2.
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Expected survival of greater than or equal to 3 months.
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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:
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Previous anticancer treatment for NHL, including chemotherapy, immunotherapy, radiation (locoregional or extended field), radioimmunotherapy, or investigational therapy.
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Known seropositivity for hepatitis C virus, hepatitis B virus (surface antigen-positive), or other active infection uncontrolled by treatment.
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Known diagnosis of human immunodeficiency virus infection.
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Presence of primary gastric, central nervous system (CNS), or testicular lymphoma, or transformed lymphoma, or chronic lymphocytic leukemia (CLL).
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Active therapy within previous 5 years for other malignancy, except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
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Abnormal liver function: total bilirubin >1.5 X upper limit of normal (ULN) or ALT
2.5 X ULN.
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Impairment of renal function (serum creatinine >1.5 X ULN) not due to lymphoma.
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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.
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Known hypersensitivity to murine and/or chimeric proteins.
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History of severe allergic or anaphylactic reactions.
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Known allergy to any components present in rituximab, cyclophosphamide, vincristine, and prednisone (CVP), or Zevalin.
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Treatment with another study treatment or approved therapy for investigational use within the 12 weeks prior to randomization.
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Exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins.
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Females with a positive pregnancy test result at screening or who are currently breastfeeding.
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Inability to comply with study requirements.
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Major surgery within 28 days except for diagnosis.
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In need of immediate intervention to treat life threatening complications.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Integrated Community Oncology Network | Jacksonville | Florida | United States | 32256 |
2 | Gulfcoast Oncology Associates | Saint 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 |
5 | Chattanooga Oncology Hematology Care | Chattanooga | Tennessee | United States | 37404 |
6 | Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
Sponsors and Collaborators
- Spectrum Pharmaceuticals, Inc
- CTI BioPharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 106NH301
Study Results
Participant Flow
Recruitment Details | |
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Pre-assignment Detail | 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. |
Arm/Group Title | All Enrolled Participants |
---|---|
Arm/Group Description | Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study. |
Period Title: Overall Study | |
STARTED | 26 |
COMPLETED | 0 |
NOT COMPLETED | 26 |
Baseline Characteristics
Arm/Group Title | All Enrolled Participants |
---|---|
Arm/Group Description | Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study. |
Overall Participants | 26 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
63
(9)
|
Sex: Female, Male (Count of Participants) | |
Female |
9
34.6%
|
Male |
17
65.4%
|
Outcome Measures
Title | Number of Participants With Adverse Events |
---|---|
Description | |
Time Frame | 18 months |
Outcome Measure Data
Analysis Population Description |
---|
Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor. |
Arm/Group Title | All Enrolled Participants |
---|---|
Arm/Group Description | Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study. |
Measure Participants | 0 |
Title | Number of Participants With Serious and Non-serious Adverse Events |
---|---|
Description | |
Time Frame | 18 months |
Outcome Measure Data
Analysis Population Description |
---|
Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor. |
Arm/Group Title | All Enrolled Participants |
---|---|
Arm/Group Description | Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study. |
Measure Participants | 0 |
Adverse Events
Time Frame | Up to end of study (approximately up to 4 years) | |
---|---|---|
Adverse Event Reporting Description | Safety data were not collected as the study was terminated early by the sponsor. | |
Arm/Group Title | All Enrolled Participants | |
Arm/Group Description | Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study. | |
All Cause Mortality |
||
All Enrolled Participants | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | |
Serious Adverse Events |
||
All Enrolled Participants | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | |
Other (Not Including Serious) Adverse Events |
||
All Enrolled Participants | ||
Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Gajanan Bhat |
---|---|
Organization | Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618 |
Phone | 949-743-9219 |
gajanan.bhat@sppirx.com |
- 106NH301