Clinical trial · Interventional
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
NCT00141726CI-TRIAL-00020025completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bronchiolitis Obliterans | — | UNRESOLVED | — |
| Lung Injury, Acute | — | UNRESOLVED | — |
| Respiratory Distress Syndrome, Adult | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etanercept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- etanercept treatment
- description
- Etanercept for lung injury
- interventionNames
- Drug: Etanercept
Primary outcomes (1)
- measure
- Percent of Patients With a Greater Than or Equal to 10% Improvement in FEV1, or FVC, and DLCO
- timeFrame
- week 12 post therapy
- 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) .
Secondary outcomes (1)
- measure
- Percentage of Participants That Experience Grade 3 to 4 Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTYanik 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. PMID 22155140