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

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 III

MedlinePlus related topics:

Lymphoma

ChemIDplus related topics:

Iodine Cadexomer iodine Sodium iodide I 131 Tositumomab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other

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

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

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
	Vallejo, California, United States, 94589
	GSK Clinical Trials Call Center
	Stanford, California, United States, 94305
	GSK Clinical Trials Call Center
	Stanford, California, United States, 94305

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
	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
	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

Study ID Numbers:	BEX104526, CCBX001-051
First Received:	October 14, 2005
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00240591
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

BEXXAR

Iodine I 131 Tositumomab

Tositumomab

low-grade follicular lymphomas

Study placed in the following topic categories:

Antibodies, Monoclonal

Lymphatic Diseases

Antibodies

Immunoproliferative Disorders

Iodine-131 anti-B1 antibody

Lymphoma, small cleaved-cell, diffuse

Lymphoma, Follicular

Iodine

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma

Follicular lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00240591