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Protocol Summary for CCBX001-053

Protocol Summary
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:
  • United States: Food and Drug Administration
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:
  • Follicular Lymphoma
  • Diffuse Large Cell Lymphoma
Keywords:
  • Transformed Diffuse Large Cell Lymphoma
Eligibility Criteria: Click to view inclusion/exclusion 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.