Targeted Therapy of Bronchiolitis Obliterans Syndrome
I. To determine if the combination treatment of FAM administered in post hematopoietic cell
transplantation (HCT) recipients after the diagnosis of new onset bronchiolitis obliterans
syndrome (BOS) can decrease the rate of treatment failure relative to an estimated
historical rate of 40% using current therapies.
I. To confirm the safety profile of FAM.
II. To describe the effect on other standard pulmonary function test parameters: forced
expiratory flow at 25%-75% of forced vital capacity (FVC) (FEF25-75), residual volume (RV),
diffusion capacity of carbon monoxide (DLCO), forced expiratory volume in 1 second
(FEV1)/FVC ratio and FEV1/slow vital capacity (SVC) ratio with FAM treatment.
III. To determine the change in molecular markers of inflammation and fibrosis in the blood
with FAM treatment.
IV. To assess the impact of FAM on other chronic graft-versus-host disease (GVHD)
V. To assess the impact of FAM on functional status, and health-related quality of life
VI. To describe changes in steroid dosing.
Patients receive fluticasone propionate inhaled orally (PO) twice daily (BID), azithromycin
PO 3 days a week, and montelukast sodium PO once daily (QD). Treatment continues for 6
months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 6 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Must be confirmed by a second PFT 2 weeks after the first measurement. A sustained, absolute decrease (worsening) of the FEV1 by >= 10% predicted in comparison to the baseline FEV1.
Within 3 months after initiation of study medications
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Stanford University||Stanford, California 94305|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|University of North Carolina at Chapel Hill||Chapel Hill, North Carolina 27599|
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|
|Weill Cornell Medical College||New York, New York 10021|
|Mayo Clinic - Scottsdale||Scottsdale, Arizona 85259|
|National Cancer Institute Experimental Transplantation & Immunology Branch||Bethesda, Maryland 20892|
|Siteman Cancer Center at Washington University||Saint Louis, Missouri 63110|