Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) Aft… (NCT00408681) | Clinical Trial Compass
CompletedNot Applicable
Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant
United States20 participantsStarted 2006-06
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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)
Exclusion Criteria:
* Significant renal dysfunction (estimated creatinine clearance \< 30 mL/min)
* Persistent or recurrent malignancy
* Secondary malignancy
* 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, sociolog…
What they're measuring
1
Functional Recovery
Timeframe: at 28 days after starting treatment with the study product