Status:
COMPLETED
Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Graft-Versus-Host Disease (GVHD) Acute on Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and tolerability of AAT in patients with steroid non-responsive acute GVHD. II. Characterize pharmacodynamic effects of AAT on pro-inflammatory cytokines,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01523821
Start Date
October 11 2013
End Date
January 15 2017
Last Update
October 30 2018
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109