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| Descriptive Information Fields | |||||
| Brief Title † | Study of Untreated or Transformed Follicular Non-Hodgkin's Lymphoma With Fission-Derived Iodine I 131 Tositumomab | ||||
| Official 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 | ||||
| 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. |
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| 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. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment | ||||
| Primary Outcome Measure † | To assess the blood pharmacokinetics in patients with previously untreated or relapsed follicular or transformed follicular non-Hodgkin's lymphoma | ||||
| Secondary Outcome Measure † | 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 | ||||
| Condition † | Non-Hodgkin's Lymphoma | ||||
| Intervention † | Drug: Iodine I 131 Tositumomab | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 12 | ||||
| Start Date † | April 2003 | ||||
| Completion Date | April 2007 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Follicular, small cleaved; Follicular, mixed small cleaved and large cell; Follicular large cell lymphoma Transformed diffuse large cell lymphoma following or concurrent with a diagnosis of follicular lymphoma.
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00062894 | ||||
| Organization ID | CCBX001-048 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | GlaxoSmithKline | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | September 2007 | ||||
| First Received Date † | June 17, 2003 | ||||
| Last Updated Date | September 13, 2007 | ||||