Protocol Summary for CCBX001-053
| Protocol Id: | CCBX001-053 |
| Secondary Ids: |
|
| Title: | A Multi-Center, Randomized, Phase III Study of Iodine I 131 Tositumomab Therapeutic Regimen versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients with Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma |
| Phase: | Phase 3 |
| 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: | 671 |
| Has Expanded Access?: | None |
| Study Type: | Interventional |
| Oversight Authority: |
|
| Collaborators: |
|
| Brief Summary: | The primary purpose of this trial is to compare safety and efficacy between Bexxar and Zevalin. |
| Detailed Description: | |
| Record Verification Date: | September 2009 |
| Status: | Not yet recruiting |
| Why Study Stopped: | |
| Study Start Date: | |
| Study Completion Date: | |
| Study Completion Date Type: | |
| Primary Completion Date: | |
| Primary Completion Date Type: | |
| Primary Purpose: | Treatment |
| Allocation: | Randomized |
| Masking: | Open Label |
| Masked Subject: | |
| Masked Caregiver: | |
| Masked Investigator: | |
| Masked Assessor: | |
| Study Design (Assignment): | Parallel Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
|
| Secondary Outcomes: |
|
| Conditions: |
|
| Keywords: |
|
| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria
|
| Gender: | Both |
| Minimum Age: | 18 Years |
| Maximum Age: | N/A |
| Enrollment: | 350 |
| Enrollment Type: | Anticipated |
| 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