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Pulmonary Complications of Hematopoietic Stem Cell Transplantation

Pulmonary Complications of Hematopoietic Stem Cell Transplantation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00837681
Enrollment
350
Registered
2009-02-05
Start date
2005-10-31
Completion date
2016-07-08
Last updated
2017-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Disease

Keywords

Bone Marrow Transplant, hematopoietic stem cell transplantation

Brief summary

The purpose of this study is to determine risk factors associated with the development of lung disease after hematopoietic stem cell transplantation. Depending on the results and findings of this study, it may be possible to predict who is at higher risk of serious complications and ultimately develop therapies to prevent or treat this lung disease.

Detailed description

The development of pulmonary complications after hematopoietic stem cell transplantation is responsible for significant morbidity and mortality. The incidence of pulmonary disease has been reported to be as high as 50% of all patients that undergo transplant. The most common manifestation of early onset lung disease is idiopathic pneumonia syndrome. This can occur in autologous and allogeneic transplants, with an incidence between 5% and 10% and a mortality rate as high as 74%(1). Late onset pulmonary disease may be even more frequent and has been reported between 10-24% in recipients of allogeneic HSCT(2-4). Additionally, a recent study demonstrated 26% of patients develop airflow obstruction after transplant and this was correlated with mortality(5). One quite useful classification system divides late onset pulmonary disease into bronchiolitis obliterans and interstitial pneumonia(4). Interstitial pneumonia is a condition characterized by diffuse infiltrates, often with lymphocyte predominance, and associated with restrictive defects on pulmonary function testing. Bronchiolitis obliterans is characterized by progressive airflow obstruction and a normal radiograph (except possibly associated air trapping). The incidence of bronchiolitis obliterans after HSCT varies widely, but is usually reported to be between 1% and 11%(6-8), although the presence of post HSCT obstructive airway disease was reported at 26% in a recent large study(5). Late onset pulmonary diseases are often treated with increased immunosuppression, but the prognosis is poor with limited response to therapy(9; 4).

Interventions

None listed

Sponsors

Karen Wood
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1\. All patients scheduled to undergo hematopoietic stem cell transplantation (HSCT)

Exclusion criteria

1. Patients whose ability to give informed consent is in question. 2. Pregnancy.

Design outcomes

Primary

MeasureTime frame
To determine factors contributing to the development of lung disease after hematopoietic stem cell transplantation (HSCTend of study

Secondary

MeasureTime frame
1b) To identify the mechanisms by which CD8+ regulatory cells suppress the alloimmune response.end of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026