Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic, Hematology |
| Therapuetic Areas: | Hematology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/14/2018 |
| Start Date: | August 2007 |
| End Date: | August 2019 |
A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease
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.
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.
- IL-2 will be given daily through an injection under the skin for a period of 8 weeks. To
determine the highest safest dose of IL-2, the dose participants receive will increase
as lower doses are determined to be safe. There will be three dose levels.
- Participants will be seen periodically while they are receiving IL-2. Physical exams and
blood tests will be performed weekly for the first two weeks and then every other week
until week 8.
determine the highest safest dose of IL-2, the dose participants receive will increase
as lower doses are determined to be safe. There will be three dose levels.
- Participants will be seen periodically while they are receiving IL-2. Physical exams and
blood tests will be performed weekly for the first two weeks and then every other week
until week 8.
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
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