Clinical trial NCT00837681: Pulmonary Complications of Hematopoietic Stem Cell Transplantation
Official title: Pulmonary Complications of Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Disease
Keywords: Bone Marrow Transplant
hematopoietic stem cell transplantation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2009-02-05
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled to undergo hematopoietic stem cell transplantation (HSCT)

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).

Eligibility criteria: 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.

Primary outcomes:
measure: To determine factors contributing to the development of lung disease after hematopoietic stem cell transplantation (HSCT
timeFrame: end of study
Secondary outcomes:
measure: 1b) To identify the mechanisms by which CD8+ regulatory cells suppress the alloimmune response.
timeFrame: end of study
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Karen Wood, MD
role: PRINCIPAL_INVESTIGATOR
References: