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
| Verified date | January 2011 |
| Source | Fred Hutchinson Cancer Research Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Federal Government |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 FHCRC 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, sociological or geographical condition potentially hampering compliance with the study protocol will be excluded |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Functional recovery | Not defined | No | |
| Primary | Mucosal anatomic recovery | Not defined | No | |
| Primary | Tolerability as assessed by NCI CTCAE v2.0 | Not defined | Yes | |
| Secondary | Chronic GVHD | Not defined | No | |
| Secondary | Recurrent or progressive malignancy | Not defined | No | |
| Secondary | Non-relapsed mortality | Not defined | No | |
| Secondary | Survival | Not defined | No | |
| Secondary | Relapse/progression-free survival | Not defined | No |
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