Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Fred Hutchinson Cancer Center
With
National Cancer Institute (NCI)
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient with a diagnosis of severe intestinal GVHD that is not improving at any time after initial treatment with glucocorticoids for at least 7 days are eligible for enrollment; measures indicating severity of GVHD will include: a) persistent diarrhea with average daily stool volumes \> 500 mL per day; or b) persistent hemorrhage that is detectable by visual inspection of the stool
Patients with denuded mucosa caused by GVHD are eligible for enrollment, regardless of prior treatment for acute GVHD; denuded mucosa is defined as loss (i.e., erosion or sloughing) of the epithelium in: a) at least one-third of the surface area in a 30 cm colonic segment (i.e., rectosigmoid, descending or transverse colon); or b) at least one fifth of the surface area of the second portion of the duodenum, as estimated by endoscopic evaluation; denuded mucosa must be documented by images of the duodenum and colon and by histologic evaluation of the colon
All subjects must provide written informed consent with the use of forms approved by the Fred Hutchinson Cancer Research Center (FHCRC) Institutional Review Board (IRB)
Patients who had autologous or syngeneic marrow transplantation
Presence of any cause of intestinal symptoms or ulceration other than GVHD
Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol will be excluded
