Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant
GVHD
A Pilot Study to Evaluate the Potential Efficacy of Lithium Carbonate for Stimulation of Intestinal Recovery In Patients With Acute Graft-versus-host Disease (GVHD)
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 6, 2006
CompletedFirst Posted
Study publicly available on registry
December 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
January 20, 2017
CompletedMarch 7, 2017
January 1, 2017
4.4 years
December 6, 2006
November 23, 2016
January 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Functional Recovery
Functional recovery was defined as partial or complete resolution of gastrointestinal manifestations of acute graft-versus-host disease. Gastrointestinal manifestations of acute graft-versus-host disease include anorexia, nausea, vomiting, diarrhea, abdominal pain and bleeding. Complete response (CR) of intestinal GVHD was defined as the absence of any symptoms referable to intestinal GVHD. Partial response (PR) was defined as clearing of abdominal pain (or withdrawal of opioid analgesic requirements in patients treated for abdominal pain) and of grossly visible bleeding if present, and resolution of diarrhea or decrease in the three day average stool volume by ≥ 500 mL in patients with stool volumes of ≥ 500 mL. Progression of GVHD was defined as an increase in the three day average stool volume by \> 500 mL, or the development of new abdominal pain (or new opioid analgesic requirements) or new intestinal bleeding.
at 28 days after starting treatment with the study product
Secondary Outcomes (12)
Duration of Treatment With the Study Product
Up to 6 months
Mucosal Anatomic Recovery
2 to 3 weeks after starting treatment with the study product
Mucosal Anatomic Recovery
4 weeks after starting treatment with the study product
Mucosal Anatomic Recovery
5 weeks after starting treatment with the study product
Mucosal Anatomic Recovery
6 to 7 weeks after starting treatment with the study product
- +7 more secondary outcomes
Other Outcomes (1)
Agents Added to Treat GVHD More Than 3 Days After Enrollment
Up to 100 days after enrollment
Study Arms (1)
Arm I
EXPERIMENTALPatients receive oral lithium carbonate once or twice daily. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Given orally
Eligibility Criteria
You may qualify 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Related Publications (1)
Steinbach G, Hockenbery DM, Huls G, Furlong T, Myerson D, Loeb KR, Fann JR, Castilla-Llorente C, McDonald GB, Martin PJ. Pilot study of lithium to restore intestinal barrier function in severe graft-versus-host disease. PLoS One. 2017 Aug 17;12(8):e0183284. doi: 10.1371/journal.pone.0183284. eCollection 2017.
PMID: 28817727DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This trial was not controlled in any scientifically valid sense of the term. Clinical management included many changes of treatment other than the use of the study product. The trial had no validated external benchmark for comparisons.
Results Point of Contact
- Title
- Paul J. Martin, M.D.
- Organization
- Fred Hutchinson Cancer Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Martin
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 6, 2006
First Posted
December 7, 2006
Study Start
June 1, 2006
Primary Completion
November 1, 2010
Study Completion
May 1, 2015
Last Updated
March 7, 2017
Results First Posted
January 20, 2017
Record last verified: 2017-01