Graft Versus Host Disease
|Recruiting||Chronic Graft Versus Host Disease (cGVHD)||Phase II||
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.
- 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
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
- Talk to your health care providers first before making decisions about your health care.
- Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.