| ID | Type | Description | Link |
|---|---|---|---|
| CCBX001-053 |
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This study has been cancelled prior to enrollment
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This is a multi-center, randomized, study to compare Iodine I 131 Tositumomab therapeutic regimen to Ibritumomab Tiuxetan therapeutic regimen in the treatment of patients with relapsed or transformed follicular non-Hodgkin's B-cell lymphoma. A total of 350 patients, approximately 175 patients per arm, will be enrolled at 30 to 40 sites in the United States.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibritumomab Tiuxetan | Drug | |||
| Iodine I 131 Tositumomab | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the proportion of subjects experiencing Grade 3/4 hematological toxicity within 120 days from completion of treatment regimen administration. |
| Measure | Description | Time Frame |
|---|---|---|
| The final analysis will be carried out when 130 events (progressive disease, death or subsequent therapy) have occurred in the control arm, expected approximately 18 months after last subject last visit. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Iowa City | Iowa | 52242 | United States | ||
| GSK Clinical Trial Call Center |
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| St Louis |
| Missouri |
| 63110 |
| United States |
| GSK Clinical Trials Call Center | Buffalo | New York | 14263 | United States |
| GSK Clinical Trials Call Center | Charleston | North Carolina | 29425 | United States |
| GSK Clinical Trial Call Center | Portland | Oregon | 97213 | United States |
| GSK Clinical Trial Call Center | Knoxville | Tennessee | 37920 | United States |
| GSK Clinical Trial Call Center | Seattle | Washington | 98109 | United States |
| GSK Clinical Trials Call Center | Tacoma | Washington | 98431 | United States |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| 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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| ID | Term |
|---|---|
| C422802 | ibritumomab tiuxetan |
| C119496 | tositumomab I-131 |
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