Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)

• Status: Completed
• Trial end date: 2017-01-15
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II trial evaluates the efficacy and adverse effects of alpha 1 anti-trypsin (AAT) for the treatment of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center
• Collaborators: National Cancer Institute (NCI); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Alpha 1-Antitrypsin; Protease Inhibitors

Criteria

Inclusion Criteria:

• 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 graft versus host disease (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, based on adjusted body weight

• Signed and dated informed consent

Exclusion Criteria:

• Patients who have received any systemic agents in addition to steroids for treatment of GVHD

• 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, defined as

• 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