Investigating abnormal cells in patients with bronchiolitis obliterans syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates abnormal clonogenic epithelial cells in patients with bronchiolitis obliterans syndrome who have undergone donor stem cell or lung transplants. It aims to characterize the phenotypes of these cells in patients at MD Anderson Cancer Center and Houston Methodist. Participants will provide blood samples and undergo airway brushings during standard bronchoscopy procedures, with medical records reviewed for additional data. The study will follow patients for up to one year to gather insights on early detection of bronchiolitis obliterans syndrome.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Allo-HCT recipients undergoing a bronchoscopy at MDACC who consent to undergoing study airway brushings in addition to clinically indicated bronchoscopic procedures (e.g. bronchoalveolar lavage)

  * 5 patients with advanced BOS - forced expiratory volume in one second (FEV1) =\< 75% predicted and meeting other National Institutes of Health (NIH) criteria (FEV1/forced vital capacity \[FVC\] ratio 0.7, presence of air trapping or graft versus host disease \[GVHD\] of another organ)
  * 5 patient with early BOS - at least 10% decline in FEV1 from baseline values, with FEV1 \>= 75% predicted, and 1 high-risk feature:

    * Active systemic chronic GVHD with new early airflow obstruction OR
    * Respiratory viral infection in last three months with resolution of viral symptoms but new airflow obstruction
  * 3 patients with no pulmonary impairment (FEV1 within 5% of baseline values)
* Lung allograft recipients undergoing a bronchoscopy at Houston Methodist who consent to undergoing study airway brushing sin addition to clinically indicated bronchoscopy procedures

  * 5 patients with BOS Stage 2 or higher (\>= 35% decline in FEV1 from baseline values)
  * 5 patient with BOS Stage 0p or 1 (10-35% decline in FEV1 from baseline values)
  * 3 patients undergoing screening bronchoscopy without decline in FEV1
  * patients with undiagnosed lung cancer and chronic obstructive pulmonary disease diagnosed by pulmonary function testing (FEV1/FVC less than the lower limit of normal with \>20 pack-year history of smoking)

Exclusion Criteria:

* Bronchoscopy performed on emergency basis for life-threatening issues as opposed to routine diagnostic testing
* Patient unwilling to give consent for study airway brushings

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Ajay Sheshadri — M.D. Anderson Cancer Center
• Study coordinator: Ajay Sheshadri
• Email: asheshadri@mdanderson.org
• Phone: 713-792-6238

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Examining the airway epithelium in children with post-infectious bronchiolitis obliterans

  This study is trying to see if there are differences in the nose lining of young children who get sick from certain viruses and later develop post-infectious bronchiolitis obliterans compared to those who don’t.

  Recruiting Institut National de la Santé Et de la Recherche Médicale, France · Marseille · NCT06140901

• Using belumosudil to prevent or treat bronchiolitis obliterans in stem cell transplant patients

  This study is testing if a new medication called belumosudil can help prevent or treat bronchiolitis obliterans in patients who have recently had a stem cell transplant.

  Recruiting at 4 sites Phase 2 Dana-Farber Cancer Institute · Stanford, California and 5 other locations · NCT05922761

• Long-term observation of lung injury in children after stem cell transplants

  This study looks at children who have had stem cell transplants to see how often they develop lung problems and how these issues affect their health over time.

  Recruiting at 9 sites Children's Hospital Medical Center, Cincinnati · San Francisco, California and 8 other locations · NCT04098445

• Inhaled LAM-001 for lung transplant patients with bronchiolitis obliterans syndrome

  This study is testing if an inhaled medication called LAM-001 can help lung transplant patients with bronchiolitis obliterans syndrome feel better and improve their lung function.

  Recruiting Phase 2 University of California, San Francisco · San Francisco, California · NCT06018766

• Biomarkers for Response to ECP in Lung Transplant Patients with CLAD

  This study tests early biomarkers from blood and MRI to see if extracorporeal photopheresis helps lung transplant patients with chronic lung allograft dysfunction.

  Recruiting at 2 sites Massachusetts General Hospital · Boston, Massachusetts and 2 other locations · NCT07434869

• Airway basal stem cell treatment for children with bronchiolitis obliterans

  This trial will try airway basal stem cell treatment to see if it is safe and helps children (28 days to 18 years) with bronchiolitis obliterans who have severe lung function loss or need ongoing oxygen or ventilator support.

  Recruiting Early Phase 1 Regend Therapeutics · Shanghai · NCT07239895

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.