Back to resultsStudy of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
Primary Purpose
Lung Injury, Acute, Respiratory Distress Syndrome, Adult, Bronchiolitis Obliterans
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Lung Injury, Acute focused on measuring Enbrel, Stem Cell Transplantation, Lung Injury
Eligibility Criteria
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.
Sites / Locations
- The University of Michigan Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
etanercept treatment
Arm Description
Etanercept for lung injury
Outcomes
Primary Outcome Measures
Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO
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
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
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.
Full Information
NCT ID
NCT00141726
First Posted
August 30, 2005
Last Updated
November 4, 2015
Sponsor
University of Michigan Rogel Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00141726
Brief Title
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury, Acute, Respiratory Distress Syndrome, Adult, Bronchiolitis Obliterans
Keywords
Enbrel, Stem Cell Transplantation, Lung Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
etanercept treatment
Arm Type
Experimental
Arm Description
Etanercept for lung injury
Intervention Type
Drug
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO
Description
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) .
Time Frame
week 12 post therapy
Secondary Outcome Measure Information:
Title
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Description
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.
Time Frame
continuously (and week 4, week 8 and week 12, week 20)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A Yanik, MD
Organizational Affiliation
The University of Michigan Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22155140
Citation
Yanik GA, Mineishi S, Levine JE, Kitko CL, White ES, Vander Lugt MT, Harris AC, Braun T, Cooke KR. Soluble tumor necrosis factor receptor: enbrel (etanercept) for subacute pulmonary dysfunction following allogeneic stem cell transplantation. Biol Blood Marrow Transplant. 2012 Jul;18(7):1044-54. doi: 10.1016/j.bbmt.2011.11.031. Epub 2011 Dec 10.
Results Reference
result
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Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
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