Pulmonary Complications of Hematopoietic Stem Cell Transplantation

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.

Study Overview

• Status: Completed
• Conditions: 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).

• Study Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
lung disease; hematopoietic stem cell transplantation (HSCT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine factors contributing to the development of lung disease after hematopoietic stem cell transplantation (HSCT	end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
1b) To identify the mechanisms by which CD8+ regulatory cells suppress the alloimmune response.	end of study

Collaborators and Investigators

• Sponsor: Karen Wood
• Investigators: Principal Investigator: Karen Wood, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (ACTUAL): July 8, 2016
• Study Completion (ACTUAL): July 8, 2016

Study Registration Dates

• First Submitted: February 4, 2009
• First Submitted That Met QC Criteria: February 4, 2009
• First Posted (ESTIMATE): February 5, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 24, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: hematopoietic stem cell transplantation; Bone Marrow Transplant
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 2005C0058