Phase 2
Completed 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
Source: ClinicalTrials.gov NCT00141726 ↗
Enrolled (actual)
34
Serious AEs
14.7%
Results posted
Jun 2014
Primary outcomePrimary: Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO — 32; 16 percent evaluable participants
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.
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 | — |
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. Informational only — not medical advice.