Protocol Summary for CCBX001-048
| Protocol Id: | CCBX001-048 |
| Secondary Ids: |
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| Title: | A Multi-Center Study to Examine the Pharmacokinetics, Whole Body and Organ Dosimetry, and Biodistribution of Fission-Derived Iodine I 131 Tositumomab for Patients with Previously Untreated or Relapsed Follicular or Transformed Follicular Non-Hodgkin's Lymphoma |
| Phase: | Phase 2 |
| Acronym: | |
| FDA Regulated Intervention?: | |
| Section 801 Clinical Trial?: | |
| Delayed Posting: | |
| IND/IDE Protocol?: | Yes |
| IND/IDE Grantor: | CBER |
| IND/IDE Number: | BB-IND 3323 |
| IND/IDE Serial Number: | 635 |
| Has Expanded Access?: | None |
| Study Type: | Interventional |
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| Brief Summary: | The purpose of this study is to assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma who have received a dosimetric dose of fission-derived iodine I 131 tositumomab. |
| Detailed Description: | This is a multi-center study in which 12 patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma will receive a dosimetric dose of fission-derived Iodine I 131 Tositumomab followed by a therapeutic dose of tellurium-derived Iodine I 131 Tositumomab. Blood Pharmacokinetics, total body clearance, tumor and organ dosimetry, and biodistribution will be assessed following administration of the dosimetric dose. |
| Record Verification Date: | September 2009 |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | April 2003 |
| Study Completion Date: | April 2007 |
| Study Completion Date Type: | None |
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| Primary Completion Date Type: | |
| Primary Purpose: | Treatment |
| Allocation: | Non-randomized |
| Masking: | Open Label |
| Masked Subject: | false |
| Masked Caregiver: | false |
| Masked Investigator: | false |
| Masked Assessor: | false |
| Study Design (Assignment): | Single Group Assignment |
| Study Classification (Endpoint): | Pharmacokinetics Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 Years |
| Maximum Age: | N/A |
| Enrollment: | 12 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | No |
| Central Contact: | US GSK Clinical Trials Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | EU GSK Clinical Trials Call Center |
| Backup Central Contact Phone: | +44 (0) 20 8990 4466 |
| Backup Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: | No locations currently recruiting for this study. |

Click to view inclusion/exclusion criteria