Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: January 10, 2002
Last updated: March 24, 2015
Last verified: November 2001
The purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, IPS) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

Condition Intervention Phase
Respiratory Distress Syndrome, Adult
Bronchiolitis Obliterans
Drug: etanercept
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 15
Study Start Date: September 2001
Estimated Study Completion Date: September 2003
Detailed Description:
Over the last 2 decades, allogeneic bone marrow transplantation (BMT) has emerged as an important treatment option for a number of malignant and non-malignant disorders. Unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic BMT. One of the main chemicals felt to cause lung damage is Tumor Necrosis Factor (TNF). Etanercept is an experimental drug that attempts to block TNF lung damage. Patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. If no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. There will be weekly blood tests and bronchoscopy after the last drug dose.

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Diagnosis of acute idiopathic pneumonia syndrome (IPS) or sub-acute lung injury
  • At least 1 year of age for IPS stratum
  • At least 6 years of age for sub-acute lung injury stratum and able to perform formal pulmonary function testing
  • At least 14 days since prior treatment with an investigational drug for graft-versus-host disease
  • Previously treated with allogeneic stem cell or bone marrow transplantation for primary disease

Exclusion criteria:

  • Documented evidence of active systemic or pulmonary infection
  • Cardiogenic failure as cause of pulmonary dysfunction
  • Known hypersensitivity to etanercept
  • Currently receiving dialysis
  • Currently receiving inotropic medications except dopamine
  • Pregnant or nursing
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Please refer to this study by its identifier: NCT00029328

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
FDA Office of Orphan Products Development
Principal Investigator: Kenneth Cooke, M.D. University of Michigan, Ann Arbor, MI
  More Information

No publications provided Identifier: NCT00029328     History of Changes
Other Study ID Numbers: FD-R-2020-01  UMCC-0078;  FD-R-002020-01 
Study First Received: January 10, 2002
Last Updated: March 24, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
TNFR-Fc fusion protein
Stem Cell Transplantation
Transplantation, Homologous
Respiratory Function Tests

Additional relevant MeSH terms:
Acute Lung Injury
Bronchiolitis Obliterans
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Bronchial Diseases
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Diseases, Obstructive
Lung Injury
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
TNFR-Fc fusion protein
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents processed this record on February 04, 2016