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The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease

Phase 2
Not Enrolling
Graft-Versus-Host Disease

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Trial Information

The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease

The standard treatment for acute graft-versus-host disease is a combination of steroids and
tacrolimus or cyclosporine. Previous work has shown that less than 50% of patients respond
fully to GVHD. Without a good response, patients often have a prolonged treatment for this
disease, often involving hospitalization and sometimes even death.

Etanercept is a drug that blocks a chemical called Tumor Necrosis Factor (TNF) from causing
damage to tissue. Etanercept (Enbrel) will be added to help improve the response to
standard treatment for graft-versus-host disease (GVHD).

This is an experimental research project. It is not known whether the etanercept will
actually improve the body's response to graft-versus-host disease. This treatment is meant
to determine if etanercept will improve your response to treatment of GVHD.

Inclusion Criteria:

- Patient may be transplanted with stem cells from any source using either a
myeloablative or nonmyeloablative preparative regimen

- Patient may be any age

- Patient must have biopsy proven new onset of aGVHD; Clinical Grading must be II-IV
and may occur after stem cell transplant or donor leukocyte infusion (DLI). Patients
may begin Etanercept treatment prior to biopsy confirmation of GVHD. Acute GVHD will
be determined by clinical presentation and not timing from stem cell infusion

- Patient must be on solumedrol at a dose of 2mg/kg/day of actual body weight for no
more than 72 hours prior to the initiation of etanercept

- Patient must have evidence of neutrophil engraftment with an ANC of > 500 for three
consecutive days

- Pulse ox > 90% on room air

Exclusion Criteria:

- Pregnancy or nursing mother

- Intolerance or allergic reaction to etanercept

- Previous use of steroids for treatment of acute GVHD

- Active infection, chronic or localized, not responding to antibiotics, with continued
signs of infection (patients with a positive C. Difficile test will not be excluded
from the study)

- Condition that might predispose to developing serious infections (i.e. active and
uncontrolled diabetes mellitus, sickle cell anemia)

- Other investigational agents for the treatment or prophylaxis of graft-vs-host
disease within the past 2 weeks

- Serum creatinine > 2.0mg/dl

- Patients being treated for acute pulmonary dysfunction (IPS) study using etanercept

- Patients with hypotension believed to be secondary to sepsis syndrome or heart
failure requiring > 1 inotropic agent, or dopamine >5mcg/kg/minute for blood pressure

- Evidence of congestive heart failure on clinical exam

- Evidence of hepatic dysfunction with an ALT or AST > 2.5 x ULN, not due to GVHD

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the response rate of etanercept when administered with steroids for treatment of biopsy proven aGVHD.

Outcome Time Frame:

at 1, 2, and 3 months

Safety Issue:


Principal Investigator

John E. Levine, MS MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Food and Drug Administration

Study ID:

UMCC 3-37



Start Date:

October 2003

Completion Date:

December 2006

Related Keywords:

  • Graft-Versus-Host Disease
  • Graft vs Host Disease



The University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109