Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Pilot Study to Evaluate the Potential Efficacy of Lithium Carbonate for Stimulation of Intestinal Recovery In Patients With Acute GVHD
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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