Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease
Condition: Graft Versus Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Intervention: Interleukin-2
Intervention description: Dose will vary depending upon when participant enters the trial: Given as a daily injection under the skin for 8 weeks.
Intervention MeSH terms: Interleukin-2
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic GVHD; Steroid refractory GVHD; allogeneic stem cell transplantation

Summary:

      The purpose of this research study is to determine the safety of IL-2 and the highest dose of
      this drug that can be given safely to people with chronic graft versus host disease (GVHD).
      Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem
      cell or cord blood transplant. The donor's immune system may recognize their body (the host)
      as foreign and attempt to "reject" it. Traditional standard therapy to treat chronic GVHD is
      prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to
      control chronic GVHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipients of allogeneic stem cell transplantation with myeloablative or
             non-myeloablative conditioning regimens

          -  Patients must be at least 180 days from the allogeneic stem cell transplantation
             procedure

          -  Steroid refractory cGVHD, defined as having persistent symptoms and signs of GVHD
             despite the use of prednisone for at least 4 weeks in the preceding 12 months without
             complete resolution of signs and symptoms.

          -  Stable dose of corticosteroids for 4 weeks prior to enrollment

          -  No addition or subtraction of other immunosuppressive medications for 4 weeks prior to
             enrollment.

          -  Adequate bone marrow, renal and hepatic function as outlined in the protocol

          -  18 years of age or older

          -  ECOG Performance Status of 0-2

        Exclusion Criteria:

          -  Ongoing prednisone requirement > 1mg/kg/day (or equivalent)

          -  Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment

          -  Concurrent ECP therapy within 4 weeks prior to enrollment

          -  Post-transplant exposure to any novel immunosuppressive medication within 100 days
             prior to enrollment

          -  Donor lymphocyte infusion within 100 days prior to IL-2 therapy

          -  Active malignant disease relapse

          -  Active, uncontrolled infection

          -  Positive serologic test for Hepatitis B or a positive serologic or nucleic acid test
             for Hepatitis C

          -  HIV seropositivity

          -  Life expectancy < 3 months

          -  Pregnancy or lactation

          -  Inability to comply with IL-2 treatment regimen

          -  Uncontrolled cardiac angina or symptomatic congestive heart failure

          -  Organ transplant (allograft) recipient