Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

Status:Active, not recruiting
Therapuetic Areas:Hematology
Age Range:18 - Any
Start Date:July 2011
End Date:August 2019

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A Phase II Trial of Daily Low-Dose Interleukin-2 (IL-2) for Steroid-Refractory Chronic Graft-Versus-Host-Disease

Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord
blood transplant. The donor's immune system may recognize the your body (the host) as foreign
and attempt to 'reject' it. This process is known as graft-versus-host-disease. It is thought
that IL-2 may help control chronic GVHD by stopping the donor's immune system from
'rejecting' your body. In this research study, we are looking to see how IL-2 can be used in
combination with steroids to treat cGVHD.

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
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