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