NCT02109809

Low-Dose Total Lymphoid Irradiation in Treating Patients With Refractory Chronic Graft-versus-Host Disease After Donor Stem Cell Transplant

A Phase I Study: Low-Dose Total Lymphoid Irradiation in the Treatment of Refractory Chronic Graft Versus Host Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety of total lymphoid irradiation (TLI) in cohorts of a selected population of refractory chronic graft-versus-host disease (GvHD) patients, given to cohorts with a total cumulative doses of TLI of 100, 150, 200, 250 or 300 centigray (cGy). SECONDARY OBJECTIVES: I. To evaluate the efficacy (failure free survival \[FFS\] at 6 months) of this therapy in the study population. II. Approximate the efficacy at different dose levels using the GvHD summary scores. TERTIARY OBJECTIVES: I. Determine the effect of this therapy on relevant subpopulations of immune cells in an attempt to elucidate a mechanism of action. OUTLINE: This is a dose-escalation study. Patients undergo LD-TLI daily for 1-2 days. After completion of study treatment, patients are followed up on day 45, at 3 and 6 months, at 1 year, and then every 6 months thereafter.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
RADIATION	total nodal irradiation	Undergo TLI
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2014-04-10
• Last updated: 2018-11-23
• Results posted: 2018-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study