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| Sponsor: | Cell Therapeutics |
|---|---|
| Information provided by: | Cell Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00384111 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Follicular Lymphoma Lymphoma, Follicular |
Drug: R-CVP + Zevalin Therapeutic Regimen Drug: R-CVP |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
| 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 |
| Enrollment: | 26 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
R-CVP plus Zevalin Therapeutic Regimen
|
Drug: R-CVP + Zevalin Therapeutic Regimen
Standard R-CVP followed by Zevalin Theraeputic 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
R-CVP
|
Drug: R-CVP
Standard R-CVP
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Florida | |
| Integrated Community Oncology Network | |
| Jacksonville, Florida, United States, 32256 | |
| Gulfcoast Oncology Associates | |
| St. Petersburg, Florida, United States, 33705 | |
| United States, Georgia | |
| Wellstar-Northwest Georgia Oncology Centers | |
| Marietta, Georgia, United States, 30060 | |
| United States, Ohio | |
| Oncology Hematology Care Inc. | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Tennessee | |
| Tennessee Oncology | |
| Nashville, Tennessee, United States, 37203 | |
| Chattanooga Oncology Hematology Care | |
| Chattanooga, Tennessee, United States, 37404 | |
| Study Director: | Igor Gorbatchevsky, M.D. | Cell Therapeutics |
More Information
| Responsible Party: | Cell Therapeutics, Inc ( Igor Gorbatchevsky, M.D. ) |
| Study ID Numbers: | 106NH301 |
| Study First Received: | October 3, 2006 |
| Last Updated: | September 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00384111 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |