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:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00109993
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of acute graft-vs-host disease (GVHD)
* Clinical grade C or D disease
* No grade C disease with single organ skin involvement
* Has undergone allogeneic stem cell transplantation within the past 100 days
* Absolute neutrophil count \> 500/mm\^3 (donor-derived \[\> 60% by peripheral blood lymphocyte chimerism analyses\])
* No development of GVHD after prior donor lymphocyte infusion
* Must have received prior prophylactic cyclosporine or tacrolimus at the onset of acute GVHD
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* No serologic evidence of active hepatitis B or C infection
Renal
* Creatinine ≤ 3.5 mg/dL
* No requirement for dialysis
Cardiovascular
* No requirement for vasopressors
Pulmonary
* No requirement for a ventilator
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No known HIV positivity
* No active uncontrolled infection
* No other organ dysfunction
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00109993
Study Brief:
Protocol Section:
NCT00109993