Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2011-06-30
2015-12-31
Brief Summary
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Detailed Description
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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.
SECONDARY OBJECTIVES:
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) manifestations.
V. To assess the impact of FAM on functional status, and health-related quality of life (HRQOL).
VI. To describe changes in steroid dosing.
OUTLINE:
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (BOS therapy)
Patients receive fluticasone propionate inhaled PO BID, azithromycin PO 3 days a week, and montelukast sodium PO QD. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
fluticasone propionate
Given inhaled PO
montelukast sodium
Given PO
azithromycin
Given PO
Interventions
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fluticasone propionate
Given inhaled PO
montelukast sodium
Given PO
azithromycin
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Forced expiratory volume in 1 second (FEV1) \< 75% of the predicted normal and FEV1 to slow or inspiratory vital capacity ratio (FEV1/SVC or FEV1/IVC) =\< 0.7, both measured before and after administration of bronchodilator OR
* Pathologic diagnosis of BOS demonstrated by lung biopsy
* The baseline absolute FEV1 must be \>= 10% lower than the pre-transplant absolute FEV1 as defined by the pre-transplant FEV1 minus the baseline FEV1, both measured before administration of a bronchodilator
* Participant (or parent/guardian) has the ability to understand and willingness to sign a written consent document
Exclusion Criteria
* Known history of allergy to or intolerance of montelukast, zafirlukast, azithromycin, erythromycin, or clarithromycin
* Pregnancy or nursing; all females of childbearing potential must have a negative serum or urine pregnancy test \< 7 days before study drug administration
* Transaminases \> 5 X upper limit of normal (ULN)
* Total bilirubin \> 3 X ULN
* Chronic treatment with any inhaled steroid for \> 1 month in the past three months
* Treatment with montelukast or zafirlukast for \> 1 month during the past three months
* Treatment with prednisone at \> 1.2 mg/kg/day (or equivalent steroid)
* Treatment with rifampin or phenobarbital, aspirin at doses \> 325 mg/day, or ibuprofen at doses \> 1200 mg/day
* Treatment with any Food and Drug Administration (FDA) non approved study medication within the past 4 weeks; off-label treatment with an FDA-approved medication is allowed
* Chronic oxygen therapy
* Evidence of any viral, bacterial or fungal infection involving the lung and not responding to appropriate treatment
* Clinical asthma (variable and recurring symptoms of airflow obstruction and bronchial hyper-responsiveness)
* Any condition that, in the opinion of the enrolling investigator, would interfere with the subject's ability to comply with the study requirements
* Uncontrolled substance abuse or psychiatric disorder
* Inability to perform pulmonary function tests (PFT) reliably, as determined by the enrolling investigator or PFT lab
* Life expectancy \< 6 months at the time of enrollment as judged by the enrolling investigator
* Baseline post-bronchodilator FEV1 \< 20% of predicted normal before or after albuterol
6 Years
99 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Stephanie Lee
OTHER
Responsible Party
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Stephanie Lee
Principal Investigator
Principal Investigators
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Stephanie Lee
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Kirsten Williams
Role: STUDY_CHAIR
National Cancer Institute (NCI)
Locations
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Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
Stanford University
Stanford, California, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
National Cancer Institute Experimental Transplantation & Immunology Branch
Bethesda, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Siteman Cancer Center at Washington University
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Vanderbilt University
Nashville, Tennessee, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Williams KM, Cheng GS, Pusic I, Jagasia M, Burns L, Ho VT, Pidala J, Palmer J, Johnston L, Mayer S, Chien JW, Jacobsohn DA, Pavletic SZ, Martin PJ, Storer BE, Inamoto Y, Chai X, Flowers MED, Lee SJ. Fluticasone, Azithromycin, and Montelukast Treatment for New-Onset Bronchiolitis Obliterans Syndrome after Hematopoietic Cell Transplantation. Biol Blood Marrow Transplant. 2016 Apr;22(4):710-716. doi: 10.1016/j.bbmt.2015.10.009. Epub 2015 Oct 22.
Inamoto Y, Martin PJ, Onstad LE, Cheng GS, Williams KM, Pusic I, Ho VT, Arora M, Pidala J, Flowers MED, Gooley TA, Lawler RL, Hansen JA, Lee SJ. Relevance of Plasma Matrix Metalloproteinase-9 for Bronchiolitis Obliterans Syndrome after Allogeneic Hematopoietic Cell Transplantation. Transplant Cell Ther. 2021 Sep;27(9):759.e1-759.e8. doi: 10.1016/j.jtct.2021.06.006. Epub 2021 Jun 12.
Other Identifiers
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NCI-2011-00203
Identifier Type: REGISTRY
Identifier Source: secondary_id
RDCRN 6503
Identifier Type: OTHER
Identifier Source: secondary_id
2367.00
Identifier Type: -
Identifier Source: org_study_id