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Complete title: Treatment of Steroid Non-responsive Acute GVHD with Alpha 1 Anti-trypsin (AAT). A Phase I/II Study
|Research Study Number||2571.00|
|Principal Investigator||Joachim Deeg, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Patients transplanted from related or unrelated, human leukocyte antigen (HLA)-matched or mismatched donors
- Patients transplanted with hematopoietic stem cells from any source
- Patients receiving calcineurin inhibitors as part of GVHD prophylaxis
- Patients with acute GVHD grades II-IV developing despite GVHD prophylaxis
- Patients who have not shown a satisfactory response to methylprednisolone-equivalent doses at 2 mg/kg/day; the weight used to dose methylprednisolone can be actual, adjusted or ideal body weight
- Signed and dated informed consent
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Patients unable to give informed consent
- Patients with manifestations of classic chronic GVHD
- Patients with evidence of recurrent malignancy
- Patients with acute/chronic GVHD overlap syndrome
- Patients whose GVHD developed after donor lymphocyte infusion (DLI)
- Patients with severe organ dysfunction
- * On dialysis
- * Requiring oxygen (O2) at more than 2 l/min
- * Uncontrolled arrhythmia or heart failure
- * Veno-occlusive disease (sinusoidal obstruction syndrome)
- Patients with uncontrolled infections
Other exclusion criteria may apply.
Hematologic Malignancies; Immunodeficiency Syndromes
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