Clinical Trials Directory

Trials / Completed

CompletedNCT00408681

Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant

A Pilot Study to Evaluate the Potential Efficacy of Lithium Carbonate for Stimulation of Intestinal Recovery In Patients With Acute Graft-versus-host Disease (GVHD)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Lithium carbonate may be an effective treatment for intestinal graft-versus-host disease caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying lithium carbonate in treating patients with acute intestinal graft-versus-host-disease after donor stem cell transplant.

Detailed description

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 hematopoietic cell transplant 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.

Conditions

Interventions

TypeNameDescription
DRUGlithium carbonateGiven orally
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2006-06-01
Primary completion
2010-11-01
Completion
2015-05-01
First posted
2006-12-07
Last updated
2017-03-07
Results posted
2017-01-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00408681. Inclusion in this directory is not an endorsement.