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

Completed · Phase 1/Phase 2

Conditions studied: Graft-Versus-Host Disease (GVHD) Acute on Chronic

In brief

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.

Key facts

Study ID

NCT01523821

Run by

Fred Hutchinson Cancer Center

People needed

20

Starts

2013-10-11

Expected to finish

2017-01-15

Last updated by the study team

2018-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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