Phase 2
N=34
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
Lung Injury, Acute · Respiratory Distress Syndrome, Adult · Bronchiolitis Obliterans
Bottom Line
View on ClinicalTrials.gov: NCT00141726 ↗Enrolled (actual)
34
Serious AEs
14.7%
Results posted
Jun 2014
Primary outcome: Primary: Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO — 32; 16 percent evaluable participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Etanercept (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- University of Michigan Rogel Cancer Center
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO |
32; 16 | — |
| SECONDARY Percentage of Participants That Experience Grade 3 to 4 Adverse Events |
14; 11; 8; 6; 6; 6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00141726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.