N/A
Completed N=20
Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant
leukemia · Childhood Myelodysplastic Syndromes · Chronic myelomonocytic leukemia · de Novo Myelodysplastic Syndromes
Source: ClinicalTrials.gov NCT00408681 ↗
Enrolled (actual)
20
Serious AEs
60.0%
Results posted
Jan 2017
Primary outcomePrimary: Functional Recovery — 10; 1; 6; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Recovery |
10; 1; 6; 3 | — |
| SECONDARY Duration of Treatment With the Study Product |
30.5 | — |
| SECONDARY Mucosal Anatomic Recovery |
2; 2 | — |
| SECONDARY Mucosal Anatomic Recovery |
2; 2 | — |
| SECONDARY Mucosal Anatomic Recovery |
2; 2 | — |
| SECONDARY Mucosal Anatomic Recovery |
2; 2 | — |
| SECONDARY Mucosal Anatomic Recovery |
2; 2 | — |
| SECONDARY Recurrent or Progressive Malignancy |
1 | — |
| SECONDARY Non-relapse Mortality |
13 | — |
| SECONDARY Survival |
7 | — |
| SECONDARY Survival |
7 | — |
| SECONDARY Survival |
7 | — |
| SECONDARY Causes of Death |
2; 11; 2; 7; 2; 1 | — |
Eligibility Criteria
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, sociological or geographical condition potentially hampering compliance with the study protocol will be excluded
Data sourced from ClinicalTrials.gov (NCT00408681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.