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

Running, not enrolling · Phase 2

Conditions studied: Chronic Graft-versus-host Disease

In brief

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.

Key facts

Study ID

NCT01366092

Run by

Dana-Farber Cancer Institute

People needed

35

Starts

2011-07-01

Expected to finish

2026-12-01

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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