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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00319332 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma, Small Cleaved-Cell, Follicular Lymphoma, Large-Cell, Follicular Lymphoma, Follicular Lymphoma, Non-Hodgkin |
Drug: Ibritumomab Tiuxetan Drug: Iodine I 131 Tositumomab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Randomized, Phase 3 Study of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen for Patients With Relapsed or Transformed Follicular Non-Hodgkin's Lymphoma |
| Estimated Enrollment: | 350 |
| Study Start Date: | September 2005 |
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, Iowa | |
| GSK Clinical Trials Call Center | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Missouri | |
| GSK Clinical Trial Call Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| GSK Clinical Trials Call Center | |
| Buffalo, New York, United States, 14263 | |
| United States, North Carolina | |
| GSK Clinical Trials Call Center | |
| Charleston, North Carolina, United States, 29425 | |
| United States, Oregon | |
| GSK Clinical Trial Call Center | |
| Portland, Oregon, United States, 97213 | |
| United States, Tennessee | |
| GSK Clinical Trial Call Center | |
| Knoxville, Tennessee, United States, 37920 | |
| United States, Washington | |
| GSK Clinical Trial Call Center | |
| Seattle, Washington, United States, 98109 | |
| GSK Clinical Trials Call Center | |
| Tacoma, Washington, United States, 98431 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| ClinicalTrials.gov Identifier: | NCT00319332 History of Changes |
| Obsolete Identifiers: | NCT00078676 |
| Other Study ID Numbers: | 393229/029, CCBX001-053 |
| Study First Received: | April 26, 2006 |
| Last Updated: | January 24, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
non-Hodgkin's Lymphoma follicular lymphoma BEXXAR ZEVALIN |
Iodine I 131 Tositumomab Ibritumomab Tiuxetan Follicular, mixed small-cleaved and large-cell Diffuse large cell non-Hodgkin's lymphoma following or concurrent with a diagnosis of follicular lymphoma |
|
Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Iodine Cadexomer iodine |
Iodine-131 anti-B1 antibody Antibodies, Monoclonal Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Antineoplastic Agents Immunologic Factors |