Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease
United States35 participantsStarted 2011-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD