Investigating abnormal cells in patients with bronchiolitis obliterans syndrome

Evaluating Clonogenic Epithelial Cell Populations in Patients With Bronchiolitis Obliterans Syndrome

This study is testing whether looking at certain abnormal cells in the blood and lungs of patients with bronchiolitis obliterans syndrome after a transplant can help doctors find this condition earlier.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT04604522 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients who have received allogeneic hematopoietic cell transplants or lung transplants and are undergoing bronchoscopy.

Not a fit: Patients without a history of bronchiolitis obliterans syndrome or those not undergoing bronchoscopy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection of bronchiolitis obliterans syndrome in transplant patients.

How similar studies have performed: While this approach is novel in the context of bronchiolitis obliterans syndrome, similar studies have shown promise in understanding cell populations in transplant patients.

Eligibility criteria

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 this trial is running

Houston, Texas

• 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

Conditions: Bronchiolitis Obliterans