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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01366092
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01366092
Study Brief:
Protocol Section:
NCT01366092