Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Iodine I 131 Tositumomab
This trial is active, not recruiting.
|Start date||August 2003|
|End date||March 2016|
|Trial size||120 participants|
|Trial identifier||NCT00240578, BEX104528, CCBX-001-052|
This is a multi-center study for the long-term follow-up of surviving patients who are expected to complete or who have completed at least two years of follow-up after treatment with Iodine I 131 Tositumomab (BEXXAR) on Studies CP-97-011, CP-98-025, CP-99-032, or CP-99-036. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long-term safety. Additionally Laboratory evaluations consisting of a TSH level and a complete blood cell (CBC) count with a differential and platelet count will be obtained annually. Additionally, patients who remain in long-term response following Iodine I 131 Tositumomab treatment will be followed for response and progression.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Chicago, IL||GSK Clinical Trials Call Center||no longer recruiting|
|Iowa City, IA||GSK Clinical Trials Call Center||no longer recruiting|
|Boston, MA||GSK Clinical Trials Call Center||no longer recruiting|
|Ann Arbor, MI||GSK Clinical Trials Call Center||no longer recruiting|
|New York, NY||GSK Clinical Trials Call Center||no longer recruiting|
|London, United Kingdom||GSK Clinical Trials Call Center||no longer recruiting|
|Manchester, United Kingdom||GSK Clinical Trials Call Center||no longer recruiting|
NONE. Analyses will be performed as described in study Protocols 104505, 393229/023, 393229/007, 104514 or 393229/028. Analyses specific to subjects in this protocol will
not be performed; instead, data will be reported as updates to each individual clinical study report in which they were first enrolled.
In addition, interim analyses of delayed toxicities of AML/MDS are reported yearly to the U.S. Food and Drug Administration.
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients must have enrolled in one of the following Corixa sponsored clinical trials: CP-97-011, CP-98-025, CP-99-032, or CP-99-036 and are >2 years post treatment with Iodine I 131 Tositumomab. - Patients must give written informed consent by signing an IRB/ethics committee approved consent form prior to entry on this follow-up study. Exclusion Criteria: - Inability to meet above referenced inclusion criteria.
|Official title||A MULTI-CENTER LONG-TERM FOLLOW-UP STUDY OF PATIENTS WITH LOW-GRADE NON-HODGKIN'S LYMPHOMA PREVIOUSLY TREATED WITH IODINE I 131 TOSITUMOMAB IN STUDIES CP-97-011, CP-98-025, CP-99-032, or CP-99-036|
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