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Alpha 1 Anti-Trypsin in Treating Patients With Acute Graft-Versus-Host Disease

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
Phase       I/II

Look up trial at NIH

Research Study Description

This phase I/II trial studies the side effects and best dose of alpha 1 anti-trypsin (alpha-1-proteinase inhibitor human) and to see how well it works in treating patients with acute graft-versus-host disease (GVHD). Alpha-1-proteinase inhibitor human may be a better treatment for graft-versus-host disease caused by a stem cell transplant.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

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, based on adjusted body weight

- Signed and dated informed consent

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

- * 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.

Research Study Number       2571.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Hematologic Malignancies; Immunodeficiency Syndromes; Graft Versus Host Disease (GVHD); Graft Versus Host Disease, Acute (aGVHD)

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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