Low-Dose Total Lymphoid Irradiation in Treating Patients With Refractory Chronic Graft-versus-Host Disease After Donor Stem Cell Transplant
NCT02109809 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2018-11-23
Summary
This phase I trial studies the side effects and best dose of low-dose total lymphoid irradiation (LD-TLI) in treating patients with chronic graft-versus-host disease that has not responded to treatment with steroids. LD-TLI is a procedure in which all of the body's major lymph nodes are treated with small doses of radiation in order to reset the dysfunctional immune system. LD-TLI may work as a treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.
Conditions
Interventions
- RADIATION
-
total nodal irradiation
Undergo TLI
- OTHER
-
laboratory biomarker analysis
Correlative studies
- OTHER
-
questionnaire administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Gordon Phillips · Wake Forest University Health Sciences
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2016-09-30
- Completion
- 2016-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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