Daily 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.

Inclusion Criteria:

- Recipient of allogeneic stem cell transplantation with myeloablative or
non-myeloablative conditioning regimens

- Steroid refractory cGVHD with systemic therapy onset within the prior 6 months

- No more than 2 prior lines of cGVHD therapy

- Estimated life expectancy > 3 months

- Adequate organ function

Exclusion Criteria:

- Ongoing prednisone requirement > 1 mg/kg/day (or equivalent)

- Concurrent use of calcineurin-inhibitors plus sirolimus

- History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic
thrombocytopenic purpura

- Active malignant relapse

- Active uncontrolled infection

- Uncontrolled cardiac angina or symptomatic congestive heart failure

- Organ transplant (allograft) recipient

- HIV-positive on combination antiretroviral therapy

- Active hepatitis B or C

- Pregnant or breast-feeding