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

Status: Recruiting
Phase: Phase 2
Diagnosis: Graft-versus-Host-Disease
NCT ID: NCT01366092 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-149

 

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.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
John Koreth, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David Avigan, MD, Beth Israel Deaconess Medical Center
Yi-Bin Chen, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Bhavjot Bindra, 617-632-6577, bhavjot_bindra@dfci.harvard.edu
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility 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
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