Patients With Low-Grade Non-Hodgkin's Lymphoma Previously Treated With Iodine I 131 Tositumomab

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240578
First received: October 14, 2005
Last updated: March 11, 2008
Last verified: March 2008
  Purpose

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.


Condition Phase
Non-Hodgkin's Lymphoma
Phase 3

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Secondary Outcome Measures:
  • 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.

Enrollment: 120
Study Start Date: August 2003
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240578

Locations
United States, Illinois
GSK Clinical Trials Call Center
Chicago, Illinois, United States, 60612
United States, Iowa
GSK Clinical Trials Call Center
Iowa City, Iowa, United States, 52242
United States, Massachusetts
GSK Clinical Trials Call Center
Boston, Massachusetts, United States, 02111
United States, Michigan
GSK Clinical Trials Call Center
Ann Arbor, Michigan, United States, 48109
United States, New York
GSK Clinical Trials Call Center
New York, New York, United States, 10021
United Kingdom
GSK Clinical Trials Call Center
London, United Kingdom, London
GSK Clinical Trials Call Center
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00240578     History of Changes
Other Study ID Numbers: BEX104528, CCBX-001-052
Study First Received: October 14, 2005
Last Updated: March 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Low-grade lymphoma
Iodine I 131 Tositumomab
BEXXAR
Long-Term Follow-up

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
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

ClinicalTrials.gov processed this record on August 01, 2014