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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT00929695
Eligibility Criteria:
Inclusion Criteria:
* Patients with newly diagnosed acute GVHD (\>= grade IIa) for whom, in the judgment of the attending physician, initial treatment with systemic glucocorticoids is indicated
* Patient or guardian able and willing to provide informed consent
Exclusion Criteria:
* Hallmarks of chronic GVHD
* GVHD after donor lymphocyte infusion (DLI)
* Patient unwilling to remain in Seattle under the care of the Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA) through day 42 after the start of treatment for GVHD
* Uncontrolled infection or other underlying comorbidity (i.e. severe psychiatric illness) that precludes the use of "standard-dose" prednisone
* Recent diagnosis of recurrent or progressive malignancy that precludes the use of "standard-dose" prednisone
* Any prior systemic therapy for acute GVHD (Patients may receive up to 2 doses of low-dose prednisone prior to randomization; low-dose prednisone is defined as 0.5 mg/kg/dose for patients who present with grade IIa GVHD and 1 mg/kg/dose for those who present with grade IIb-IV GVHD)
* Enrollment on Blood and Marrow Transplant Clinical Trials Network (BMT-CTN) trial 0802
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00929695
Study Brief:
Protocol Section:
NCT00929695