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| Sponsored by: |
GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00268983 |
Purpose
Comparison of rituximab versus Iodine I 131 Tositumomab therapeutic regimen in subjects with follicular non Hodgkins B cell lymphoma. 506 subjects will be enrolled at 30 to 40 sites in the US, Canada, and Europe. Subjects will be randomly assigned to one of two treatment arms. In Arm A, subjects will receive 375 milligrams/meter2 (mg/m2 )of rituximab, given as an intravenous (IV) infusion once weekly for 4 weeks. In Arm B, subjects will undergo a two-phase treatment. In the first phase, termed the "dosimetric dose," subjects will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of 5 millicuries (mCi) (0.18 gigabecquerel [GBq]) of Iodine 131 Tositumomab (35 mg). Whole body gamma camera scans will be obtained three times (Day 0; Day 2, 3, or 4; and Day 6 or 7) following the dosimetric dose. The information derived from the scans will enable a patient specific dose to be calculated to deliver the desired total body dose of radiation (65 or 75 centigray [cGy]). In the second phase, termed the "therapeutic dose," subjects in Arm B will receive an infusion of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the subject specific activity of Iodine 131-conjugated Tositumomab (35 mg). Thyroid blockade will be implemented 24 hours prior to the dosimetric dose and continued for 14 days following the therapeutic dose. Subjects on study will be followed for response and safety at Week 7, Week 13, and every three months for the first and second year, every six months for the third year, and then annually for the forth and fifth years; and then for vital status, additional therapy, and long term safety events through year ten. Follow Up after subsequent NHL therapy will be carried out to assess tolerance of next anti-lymphoma therapy, development of myelodysplasia (MDS)/acute myelogenous leukemia (AML), HAMA or hypothyroidism, unexpected safety issues, and death.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: Iodine I 131 Tositumomab Therapeutic Regimen Drug: Rituximab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Randomized, Phase 3 Study of Rituximab Versus Iodine I 131 Tositumomab Therapeutic Regimen For Patients With Relapsed Follicular Non-Hodgkins Lymphoma |
| Estimated Enrollment: | 506 |
| Study Start Date: | October 2004 |
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, Washington | |
| GSK Investigational Site | |
| Walla Walla, Washington, United States, 99362 | |
| United Kingdom, Lancashire | |
| GSK Investigational Site | |
| Manchester, Lancashire, United Kingdom | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 393229/028, CCBX001-049 |
| Study First Received: | December 21, 2005 |
| Last Updated: | May 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00268983 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
non-Hodgkins lymphoma NHL rituximab |
|
Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, Follicular Iodine-131 anti-B1 antibody Trace Elements Follicular Lymphoma Lymphoma, Small Cleaved-cell, Diffuse Antibodies, Monoclonal Anti-Infective Agents, Local |
Lymphatic Diseases Antibodies Iodine Micronutrients Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |
|
Anti-Infective Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Growth Substances Physiological Effects of Drugs Lymphoma, Follicular Iodine-131 anti-B1 antibody Trace Elements |
Pharmacologic Actions Antibodies, Monoclonal Anti-Infective Agents, Local Lymphatic Diseases Neoplasms Therapeutic Uses Iodine Micronutrients Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |