|Closed||Graft Versus Host Disease||Phase I/II||
This phase I/II trial studies the side effects and best dose of alpha 1 anti-trypsin and to see how well it works in treating patients with acute graft-versus-host disease (GVHD). Alpha 1 anti-trypsin may be an effective treatment for graft-versus-host disease caused by a stem cell transplant
- Patients transplanted from related or unrelated, human leukocyte antigen (HLA)-matched or mismatched donors
- Any source of hematopoietic stem cells is allowed
- Patients may have received any GVHD prophylactic regimen, but developed acute GVHD grades II-IV
- Patients will have received primary therapy with steroids, but showed progression of or did not resolve clinical manifestations of GVHD on methylprednisolone doses >= 1mg/kg; criteria and indications for secondary systemic therapy of acute GVHD have not been systematically defined; according to American Society for Blood and Marrow Transplantation (ASBMT) guidelines, both severity and duration of manifestations of GVHD will be taken into consideration when deciding that steroid treatment has not adequately controlled GVHD; in general, the decision to initiate secondary therapy will be made sooner for patients with more severe GVHD; for example, secondary therapy may be indicated after 3 days with progressive manifestations of GVHD, after 1 week with persistent, unimproving grade III GVHD or after 2 weeks with persistent, unimproving grade II GVHD; secondary systemic therapy may also be indicated earlier in patients who cannot tolerate high-dose glucocorticoid treatment
- Patients who have received agents in addition to steroids for therapy of GVHD
- Unable to give informed consent
- Patients with manifestations of classic chronic GVHD
- Patients with evidence of recurrent malignancy
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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