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Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141726
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : June 19, 2014
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Brief Summary:
The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an improved quality of life in these patients.

Condition or disease Intervention/treatment Phase
Lung Injury, Acute Respiratory Distress Syndrome, Adult Bronchiolitis Obliterans Drug: Etanercept Phase 2

Detailed Description:

Lung or breathing problems can develop several months to years following a bone marrow transplant. In some cases, these breathing problems develop without any signs of germs or infection in the lungs. The name for this type of breathing problem is called "Sub-Acute Lung Injury". Sub-acute lung injury often develops many months, even years following a bone marrow transplant. It is often characterized by shortness of breath, cough, wheezing and fatigue.

Sub-acute lung injury can either lead to the formation of scar tissue in the lungs (making it difficult to take deep breaths), or it can cause the lungs to get weak (making people feel out of breath easily). Approximately 25 - 50% of patients with sub-acute lung injury may eventually die from the damage in their lungs. Typically, such patients die from infections that develop inside the damaged lungs.

In this study, treatment with an experimental drug called Etanercept will be used. (Enbrel). The physicians feel there is the possibility that Etanercept may help improve breathing. Breathing ability will be assessed prior to treatment as well as during and after treatment so that comparisons can be made.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study
Study Start Date : October 2003
Actual Primary Completion Date : July 2008
Actual Study Completion Date : February 2009

Arm Intervention/treatment
Experimental: etanercept treatment
Etanercept for lung injury
Drug: Etanercept
Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.
Other Name: Enbrel

Primary Outcome Measures :
  1. Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO [ Time Frame: week 12 post therapy ]
    Response was defined as a greater than or equal to 10% improvement in the absolute value for FEV1 (for obstructive defects) or FVC (for restrictive defects), and DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide) .

Secondary Outcome Measures :
  1. Percentage of Participants That Experience Grade 3 to 4 Adverse Events [ Time Frame: continuously (and week 4, week 8 and week 12, week 20) ]
    To evaluate the toxicity of etanercept therapy in patients with sub-acute lung injury > 100 days post transplant, the percent incidence of grade 3 to 4 adverse events among evaluable patients was calculated.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Recipients of allogeneic bone marrow, cord blood, or peripheral blood stem cell transplants are eligible
  • Age >6 years and able to complete pulmonary function testing
  • Patients with evidence of sub-acute, non-infectious pulmonary dysfunction (OLD or RLD)
  • Recipients of sub-ablative transplant regimens are eligible
  • Recipients of donor leukocyte infusions (DLI) post-transplant are eligible
  • Patients must be > 100 days post transplant

Exclusion Criteria:

  • Patients with hypotension requiring inotropic agents other than dopamine < 5mcg/ kg/ minute for blood pressure support.
  • Patients with a positive quantitative bacterial culture from the BAL fluid (≥ 104 CFU/ ml is considered positive)
  • Patients whose BAL fluid is positive for significant bacterial pathogens or pathogenic nonbacterial microorganisms (as defined by protocol) by special stain, culture or PCR analysis
  • Patients who are enrolled on a phase I or phase II trial for the prophylaxis or treatment of GVHD (acute or chronic) within 7 days of study entry.
  • Patients with known hypersensitivity to etanercept.
  • Patients who are pregnant.
  • Patients with CMV seropositivity at the time of study entry. Testing may include wither CMV PCR analysis or CMV pp65 testing.
  • Evidence for multi-system organ failure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141726

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United States, Michigan
The University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
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Principal Investigator: Gregory A Yanik, MD The University of Michigan Comprehensive Cancer Center
Publications of Results:
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Responsible Party: University of Michigan Rogel Cancer Center Identifier: NCT00141726    
Other Study ID Numbers: UMCC 3-31
IRBMED 2003-0590 and HUM 46747 ( Other Identifier: University of Michigan Medical IRB )
First Posted: September 1, 2005    Key Record Dates
Results First Posted: June 19, 2014
Last Update Posted: December 3, 2015
Last Verified: November 2015
Keywords provided by University of Michigan Rogel Cancer Center:
Stem Cell Transplantation
Lung Injury
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Lung Injury
Bronchiolitis Obliterans
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
Thoracic Injuries
Wounds and Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors