Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT00529035
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00529035
Study Brief:
Protocol Section:
NCT00529035