Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408681
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2006-12-06
Brief Title:
Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease GVHD After Donor Stem Cell Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
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
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GVHD
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-00269 | None | None | None |