A Pilot Study to Evaluate the Potential Efficacy of Lithium Carbonate for Stimulation of Intestinal Recovery In Patients With Acute GVHD
PRIMARY OBJECTIVES:
I. To evaluate the effects of lithium on functional and mucosal anatomic recovery in the
small or large bowel of patients with acute GVHD.
II. Functional recovery will be evaluated according to changes in clinical manifestations of
gastrointestinal GVHD. III. Mucosal anatomic recovery will be evaluated by review of results
from clinically indicated endoscopic evaluations.
SECONDARY OBJECTIVES:
I. To assess the tolerability of lithium administration in allogeneic HCT recipients.
OUTLINE: Patients receive oral lithium carbonate once or twice daily. Treatment continues
for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Functional recovery
Not defined
No
Paul Martin
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
2080.00
NCT00408681
June 2006
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |