Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Phase phase 3
Sponsor GlaxoSmithKline
Start date August 2003
End date March 2016
Trial size 120 participants
Trial identifier NCT00240578, BEX104528, CCBX-001-052

Summary

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

Secondary Outcomes

Measure
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
time frame:
not be performed; instead, data will be reported as updates to each individual clinical study report in which they were first enrolled.
time frame:
In addition, interim analyses of delayed toxicities of AML/MDS are reported yearly to the U.S. Food and Drug Administration.
time frame:

Eligibility Criteria

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.