The Longitudinal Impact of Respiratory Viruses on Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Cell Transplantation (The RV-BOS Study)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8+
SponsorFred Hutchinson Cancer Center

About this trial

This observational trial studies whether respiratory viruses are the cause of lung disease (bronchiolitis obliterans syndrome \[BOS\] or graft-versus-host disease of the lung) and changes in lung function in patients who have received a donor stem cell transplant. Patients with chronic graft-versus-host disease (cGVHD) are at higher risk of developing BOS. Studies have also shown that patients who had a respiratory viral illness early after their transplant are at higher risk of developing lung problems later on. Patients who are at risk and who already have BOS might benefit from being monitored more closely. Spirometry is a way of assessing a patient's lung function and is often used to diagnose lung disease. Spirometry measured at home with a simple handheld device may reduce the burden of performing pulmonary function testing at a facility and potentially help patients get their lung disease diagnosed and treated sooner.

Eligibility criteria

Qualifiers

Allogeneic HCT recipients with any indication, graft source, donor type, or conditioning regimen

Age 8 and older

A diagnosis of cGVHD as per NIH criteria through 5 years of diagnosis.

At 'Day 80' evaluation. D80 designates a posttransplant landmark, usually between 70-120 days, in which patients are evaluated for discharge back to community care. Patients with the following occurrences can be enrolled with 3 months of the Day 80 post-transplant evaluation.

Disqualifiers

Diagnosis of BOS at time of enrollment (Cohort 1 only)

Life expectancy < 2 years.

Diagnosis of active hematologic relapse or malignancy requiring active treatment that will affect that patient's ability to comply with study procedures.

Patient should not have a clinically acute active lower respiratory tract infection or a clinically acute active noninfectious respiratory condition (i.e. COPD exacerbation, pleural effusion) at the time of enrollment. However, patient may become eligible once these conditions have stabilized or resolved as noted above.

Trial design

Treatments tested in this trial

  • Home spirometry
  • Biospecimen Collection
  • Questionnaire Administration

Treatment groups

250 Participants
are divided into 1 treatment group

Sponsors and collaborators

Fred Hutchinson Cancer Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator