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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); Prometheus Laboratories
• Treatments: Interleukin-2

Criteria

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