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Bronchiolitis Obliterans SyndromeNCT05250037

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

An observational study of Bronchiolitis Obliterans Syndrome and Hematopoietic and Lymphoid Cell Neoplasm, run by Fred Hutchinson Cancer Center at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 years and older
What is being tested?
Home spirometry, Biospecimen Collection and Questionnaire Administration
How many people
261 participants
Where
4 sitesUnited States
Study dates
30 Mar 2022to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Allogeneic hematopoietic cell transplant recipients, age 8 and up.

Who may be able to join

  • Allogeneic HCT recipients with any indication, graft source, donor type, or conditioning regimen
  • Age 8 and older
  • COHORT 1 Inclusion criteria: One or more of the following clinical scenarios that encompass increased risk for BOS:
  • A diagnosis of cGVHD as per NIH criteria through 5 years of diagnosis.
  • New diagnosis of cGVHD within 3 months. This window may be extended by 30 days on a case-by-case basis.
  • A diagnosis of cGVHD ≥ 3 months and ≤ 5 years, with a new FEV1 decline of ≥10% in absolute value within 6 weeks compared with PFT done within the prior 2 years.
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  • A recent documented respiratory infection of any etiology that has been clinically managed and stabilized or improving as determined by a clinician, within 8 weeks.
  • Progression of flare of chronic GVHD requiring an alteration in therapy as determined by a clinician, within 3 months.
  • 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.
  • FEV1 decline of 10% in absolute values compared with pretransplant baseline. ii. Documented posttransplant RVI. iii. Lower respiratory tract disease (LRTD) of any etiology.
  • COHORT 2 inclusion criteria: Newly diagnosed BOS within 6 weeks of clinical recognition. This may include the following scenarios:
  • "Early BOS", ie patients with new airflow decline and obstruction, not yet meeting the FEV1 cut-off of < 75% predicted by FEV1, in the absence of other etiologies as determined by clinical investigations including chest imaging and microbiologic studies.
  • NIH-defined BOS:
  • FEV1 < 75% predicted, with a decline in absolute FEV1 > 10% compared to pretransplant baseline or within the prior 2 years. Absolute decline in FEV1 should remain >10% after bronchodilator response.
  • FEV1/FVC or FEV1/VC <0.7, or Lower Limit of Normal as per accepted reference standards. Reference standards may include National Health and Nutrition Examination Survey III or Global Lung Initiative.
  • Absence of an alternative diagnosis, including COPD exacerbation, asthma, and active respiratory tract infection, as determined by appropriate clinical investigations that may include chest imaging, microbiologic cultures, and/or bronchoscopy.
  • One of two supportive features of BOS:
  • a. Evidence of air trapping by PFTs: RV>120%, or elevated RV/TLC (>20% of predicted value)
  • b. High resolution chest CT with inspiratory and expiratory cuts that show findings that are consistent with small airways disease including (but not exclusive of) air trapping, bronchial wall thickening, or bronchiectasis.
  • BOS with atypical spirometric pattern
  • FEV1 <80%, with a preserved FEV1/FVC ratio (≥0.7) and TLC ≥80% in the absence of other clinically determined lung disease.
  • Clinical or suspected diagnosis of BOS not otherwise meeting above criteria.
  • Patient should have an Android or iOS-based smartphone with reliable access to Wi-Fi for data to be transmitted electronically. Android smartphones should have a software version of 4.0 or higher; iOS phones should have a version of 8.0 or higher.
  • Patient should be willing and able to communicate electronically in English or Spanish.

Who cannot join

  • 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.
  • Inability or unwillingness to perform the study procedures, most of which are performed at home.
  • Lack of a personal iOS or Android smartphone.
  • Inability or unwillingness to communicate electronically.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Stanford Cancer Institute

    Palo Alto, California, 94304

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

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.

Read the detailed description

OUTLINE:

This is an observational study.

Patients undergo home spirometry measurements with a portable handheld spirometer and complete questionnaires weekly, a nasal swab for viral polymerase chain reaction (PCR) surveillance every 4 weeks, and undergo blood collection and nasal swabs every 3 months for up to 2 years. (The minimum required follow-up is 1 year, but there is an optional 1 year extension period.)

Being tested
Home spirometry, Biospecimen Collection, Questionnaire Administration
Medical subject headings
Bronchiolitis Obliterans Syndrome, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home spirometryProcedure or surgery

    Also called SPIROMETRY

    Undergo spirometry measurements

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo nasal and/or oral swabs, and blood collection

  • Questionnaire AdministrationOther

    Complete questionnaires

Study groups in NCT05250037
Study groupRoleWhat they receive
Screening (spirometry measurements)Patients undergo home spirometry measurements with a portable handheld spirometer and complete questionnaires weekly, a nasal swab for viral polymerase chain reaction (PCR) surveillance every 4 weeks, and undergo blood collection and nasal swabs every 3 months for up to 2 years.
Receives: Procedure: Home spirometry; Procedure: Biospecimen Collection; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of bronchiolitis obliterans syndrome (BOS)

    Diagnosed by National Institute of Health criteria or clinical diagnosis in the absence of alternative diagnosis.

    Measured: Up to 2 years

  2. Pulmonary impairment

    Defined by temporal decline in forced expiratory volume in the first second (FEV1) determined by assessment of spirometry data.

    Measured: Up to 2 years

Secondary outcomes (6)

  1. Time from respiratory viral infection and chronic graft-versus-host disease to FEV1 decline

    Measured: Up to 2 years

  2. FEV1 (percent predicted) at clinical recognition of BOS

    Measured: Up to 2 years

  3. Incidence of asymptomatic and symptomatic viral infections

    Will be determined by the longitudinal follow-up of this observational study.

    Measured: Up to 2 years

  4. Incidence of late onset noninfectious pulmonary complications

    Will be determined by the longitudinal follow-up of this observational study. Follow-up of clinical encounters will provide an epidemiology of the incidence of noninfectious and infectious pulmonary complications.

    Measured: Up to 2 years

  5. Incidence of non-viral infectious pulmonary complications

    Will be determined by the longitudinal follow-up of this observational study. Follow-up of clinical encounters will provide an epidemiology of the incidence of noninfectious and infectious pulmonary complications.

    Measured: Up to 2 years

  6. Establishment of a biorepository that includes blood samples, respiratory viral samples, and nasal microbiome samples from patients with clinically recognized BOS

    The biorepository including self-collected samples will be catalogued and organized in a central location that can be easily accessed through a gatekeeper system.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2022
  2. Study start30 Mar 2022
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05250037
Sponsor's protocol ID
RG1121806
Other IDs
NCI-2021-13375, 10767, R01HL161037
Status last verified
Jul 2026
First submitted
20 Jan 2022
Last updated
27 Jul 2026
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiolitis Obliterans Syndrome and Hematopoietic and Lymphoid Cell Neoplasm, run by Fred Hutchinson Cancer Center at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of bronchiolitis obliterans syndrome (BOS) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05250037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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