This research study is studying a drug as a possible treatment for Bronchiolitis Obliterans Syndrome (BOS) after having an Allogeneic Hematopoietic Cell Transplantation (HCT).
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved ruxolitinib for this specific disease but it has been approved for other uses. In this study the investigators are assessing the safety and effectiveness of ruxolitinib when given to participants who have been diagnosed with BOS after HCT. BOS is a sign/symptom of chronic Graft-vs-Host Disease (GVHD), a condition in which cells from the donor's tissue attack the organs after HCT occurs. Ruxolitinib blocks certain proteins called tyrosine kinases. Specifically, it blocks tyrosine kinases called JAK2. The investigators believe that ruxolitinib may lower the rate of GVHD through its ability to block the JAK2 pathway since this pathway can lead to inflammation in the body.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Ruxolitinib blocks certain proteins called tyrosine kinases. Specifically, it blocks tyrosine kinases called JAK2. it's believe that ruxolitinib may lower the rate of GVHD through its ability to block the JAK2 pathway since this pathway can lead to inflammation in the body
City of Hope Cancer Center
Duarte, California, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Cleveland Clinic
Cleveland, Ohio, United States
absolute FEV1 increase
The proportion of participants with a sustained, absolute FEV1 increase by ≥ 10% after 3 months of treatment with ruxolitinib (compared to baseline measure prior to study enrollment) among participants with newly diagnosed Bronchiolitis Obliterans Syndrome BOS.
Time frame: 3 Months
treatment failure, comparing 3-month FEV1 to baseline FEV1
The proportion of participants who do not experience a sustained, absolute decrease in FEV1 by ≥ 10% after 3 months of treatment with ruxolitinib (compared to baseline measure prior to study enrollment) among participants with established Bronchiolitis Obliterans Syndrome BOS.
Time frame: 3 Months
Change scores for PFT measurements
Change in pulmonary function test (PFT) measurements.
Time frame: 1 Year
Improvements in chronic GVHD organ manifestations
Improvements in chronic GVHD organ manifestations will be categorized according to the NIH chronic GVHD consensus criteria.
Time frame: 3 and 6 Months
Overall survival
Time frame: 2 Years
cGVHD progression-free survival
cGVHD progression-free survival is defined as the time from registration to the earlier of progression of chronic GVHD or death due to any cause. Participants alive without cGVHD progression are censored at the date of last disease evaluation.
Time frame: 2 Years
The incidence and types of serious adverse events
Adverse events are graded according to Common Terminology Criteria for Adverse Events (CTCAE v4).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Time frame: From the start of treatment until 30 days after the end of treatment, up to 13 months total
The total systemic corticosteroid dose longitudinally over time
Time frame: 2 years