NCT00141713

Brief Summary

Etanercept (Enbrel) will be added to standard therapy for acute Graft-versus-Host Disease to see if the effectiveness of standard therapy can be improved. Partial Funding Source- FDA OOPD

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

3.1 years

First QC Date

August 30, 2005

Last Update Submit

March 12, 2013

Conditions

Graft-Versus-Host Disease

Outcome Measures

Primary Outcomes (1)

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

    at 1, 2, and 3 months

Secondary Outcomes (1)

  • To analyze intracellular cytokine levels, lymphocyte phenotype and plasma cytokine levels in patients with aGVHD before and after treatment with etanercept and to correlate these laboratory endpoints with clinical outcomes during the trial.

    at 1, 2, and 3 months

Study Arms (1)

1

EXPERIMENTAL

etanercept treatment for GVHD

Drug: Etanercept

Interventions

EtanerceptDRUG

Patients enrolled on the study will receive etanercept at 0.4 mg/kg per dose up to a maximum of 25 mg per dose subcutaneously twice a week. Etanercept must be initiated within 72 hours of starting solumedrol.

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 support
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Levine JE, Paczesny S, Mineishi S, Braun T, Choi SW, Hutchinson RJ, Jones D, Khaled Y, Kitko CL, Bickley D, Krijanovski O, Reddy P, Yanik G, Ferrara JL. Etanercept plus methylprednisolone as initial therapy for acute graft-versus-host disease. Blood. 2008 Feb 15;111(4):2470-5. doi: 10.1182/blood-2007-09-112987. Epub 2007 Nov 27.

    PMID: 18042798DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • John E. Levine, MS MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

October 1, 2003

Primary Completion

November 1, 2006

Study Completion

December 1, 2006

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

US(1)