A Phase II Trial of Daily Low-Dose Interleukin-2 (IL-2) for Steroid-Refractory Chronic Graft-Versus-Host-Disease
You will give yourself or be given IL-2 daily through an injection under your skin. You
should rotate the injection site, if possible. You will do this once every day for 12 weeks.
You will then have 4 weeks off of IL-2. During the first 6 weeks of IL-2, you will continue
to take steroids without changing the dose your doctor has set for you while you are on
IL-2. After 6 weeks of IL-2 therapy, your doctor may reduce the amount of steroids you take.
While you are on study, a member of the study team will examine you to evaluate your cGVHD.
These assessments may include examination of your skin, joints/muscles, eyes, mouth, lungs
and gastrointestinal system.
You will have clinic visits for evaluation of toxicity and clinical benefit approximately
every 4 weeks. You will also have immunologic assays approximately every 8 weeks.
Immunologic assays will measure the effect of IL-2 on immune cells.
You will be on the study for about 16 weeks. You may continue on study treatment for longer
if you experience a clinical benefit.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the overall response rate of low-dose daily SC IL-2 in steroid-refractory cGVHD
John Koreth, MBBS, DPhil
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|