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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by GlaxoSmithKline.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240591
First received: October 14, 2005
Last updated: March 11, 2008
Last verified: March 2008
  Purpose

This is a study for the long-term follow-up of patients who completed at least two years of follow-up after treatment with Tositumomab and/or Iodine I 131 Tositumomab (BEXXAR)on Study RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004 or CP-97-012. All patients will be assessed for survival and disease status, including subsequent therapy for NHL, and for long term safety. Laboratory evaluations consisting of a TSH level (for all patients) and a complete blood cell (CBC) count with a differential and platelet count (for patients in continuing response only) will be obtained annually through Year 10 post treatment with Tositumomab and/or Iodine I 131 Tositumomab.

Patients that remain in response to their previous treatment with BEXXAR, will additionally be followed radiographically 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 TOSITUMOMAB AND/OR IODINE I 131 TOSITUMOMAB IN STUDIES RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004, or CP-97-012

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 RIT-I-000, RIT-II-001, RIT-II-002, RIT-II-004, and CP-97-012. Analyses restricted to patients in this study will not be performed.

Enrollment: 150
Study Start Date: December 2003
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (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: RIT-I-000, RIT-II-001, RIT-II-002, RIT II-004 or CP-97-012 and are >2 years post Tositumomab and/or Iodine I 131 Tositumomab administration.
  • 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 the 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: NCT00240591

Locations
United States, Alabama
GSK Clinical Trials Call Center
Birmingham, Alabama, United States, 35233
United States, California
GSK Clinical Trials Call Center
Stanford, California, United States, 94305
GSK Clinical Trials Call Center
Vallejo, California, United States, 94589
United States, Connecticut
GSK Clinical Trials Call Center
New Haven, Connecticut, United States, 06520
United States, District of Columbia
GSK Clinical Trials Call Center
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Clinical Trials Call Center
Miami, Florida, United States, 33136
United States, Illinois
GSK Clinical Trials Call Center
Chicago, Illinois, United States, 60612
United States, Michigan
GSK Clinical Trials Call Center
Ann Arbor, Michigan, United States, 48109
United States, Nebraska
GSK Clinical Trials Call Center
Omaha, Nebraska, United States, 68198
United States, New York
GSK Clinical Trials Call Center
New York, New York, United States, 10021
United States, Texas
GSK Clinical Trials Call Center
Dallas, Texas, United States, 75204
GSK Clinical Trials Call Center
Houston, Texas, United States, 77030
United States, Virginia
GSK Clinical Trials Call Center
Fairfax, Virginia, United States, 22031
United States, Washington
GSK Clinical Trials Call Center
Seattle, Washington, United States, 98109
United Kingdom
GSK Clinical Trials Call Center
London, United Kingdom, ECIA 7BE
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: NCT00240591     History of Changes
Other Study ID Numbers: BEX104526, CCBX001-051
Study First Received: October 14, 2005
Last Updated: March 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
BEXXAR
Iodine I 131 Tositumomab
Tositumomab
low-grade follicular lymphomas

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 July 22, 2014