- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00141726
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- The University of Michigan Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: etanercept treatment
Etanercept for lung injury
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO
Time Frame: week 12 post therapy
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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) .
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week 12 post therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants That Experience Grade 3 to 4 Adverse Events
Time Frame: continuously (and week 4, week 8 and week 12, week 20)
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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.
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continuously (and week 4, week 8 and week 12, week 20)
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Collaborators and Investigators
Investigators
- Principal Investigator: Gregory A Yanik, MD, The University of Michigan Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Lung Diseases
- Wounds and Injuries
- Infant, Newborn, Diseases
- Bronchial Diseases
- Lung Diseases, Obstructive
- Infant, Premature, Diseases
- Thoracic Injuries
- Bronchitis
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
- Lung Injury
- Bronchiolitis
- Bronchiolitis Obliterans
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- UMCC 3-31
- IRBMED 2003-0590 and HUM 46747 (Other Identifier: University of Michigan Medical IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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