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Study was terminated early as per the Sponsor's decision.
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| Name | Class |
|---|---|
| CTI BioPharma | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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). |
|
| 2 | Active Comparator | Participants will receive standard R-CVP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zevalin Therapeutic Regimen | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious and Non-serious Adverse Events | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrated Community Oncology Network | Jacksonville | Florida | 32256 | United States | ||
| Gulfcoast Oncology Associates |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| R-CVP | Drug | Standard R-CVP |
|
| St. Petersburg |
| Florida |
| 33705 |
| United States |
| Wellstar-Northwest Georgia Oncology Centers | Marietta | Georgia | 30060 | United States |
| Oncology Hematology Care Inc. | Cincinnati | Ohio | 45242 | United States |
| Chattanooga Oncology Hematology Care | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Participants | Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor. | Posted | 18 months |
|
| ||||||||||||||||||||
| Secondary | Number of Participants With Serious and Non-serious Adverse Events | Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor. | Posted | 18 months |
|
|
Up to end of study (approximately up to 4 years)
Safety data were not collected as the study was terminated early by the sponsor.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Enrolled Participants | Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study. | 0 | 0 | 0 | 0 | 0 | 0 |
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Outcome measures and safety data were not collected and summarized as the study was terminated early by the sponsor.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gajanan Bhat | Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618 | 949-743-9219 | gajanan.bhat@sppirx.com |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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