A Phase 2 interventional study of Ruxolitinib in Hematopoietic Stem Cell Transplant (HSCT) and Bronchiolitis Obliterans (BO), sponsored by Children's Hospital Medical Center, Cincinnati. Terminated at 2 sites in United States. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 2, Interventional, and Treatment
Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy, and lung injury affects as many as 25% of children receiving HSCT. Improved transplant techniques and major improvements in survival mean that HSCT is being more widely used, and more mismatched grafts are being used. Bronchiolitis obliterans (BO) is a major limitation of pediatric HSCT success as BO is commonly diagnosed late in children, when lung injury is irreversible, leading to long term morbidity or even death. Currently, there are major gaps in our knowledge regarding incidence, etiology and optimal treatment of BO following HSCT, and important diagnostic limitations specific to children. Diagnosis of BO is usually based on performance of pulmonary function tests, which is usually impossible in ill children under 10. Even older children who feel unwell or un-cooperative may be unable to produce interpretable data. These deficiencies in diagnosis mean that BO is commonly diagnosed late, meaning fibrosis has occurred and lesions are irreversible.
The hypothesis for this interventional trial is that early treatment with standard Flovent/montelukast and steroids plus ruxolitinib will reverse lung injury and reduce the frequency of chronic pulmonary impairment or florid BO.
87 studies on the registry are indexed under Bronchiolitis Obliterans; 11 are open to participants now.
This study's enrollment of 7 is below the median of 30 across 59 interventional studies indexed under Bronchiolitis Obliterans.
Browse Bronchiolitis Obliterans studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects ≥ 5 years and ≤ 60 years of age who have undergone allogeneic HCT AND exhibit early lung dysfunction as defined by any one of the following:
AND - All age groups, including adults:
Adequate renal function defined as estimated Creatinine Clearance (CrCl) ≥ 30 mL/min as calculated by the cystatin c GFR or nuclear GFR
Adequate hepatic function as defined by:
Adequate hematological function defined as:
PT/INR \<2 x ULN and PTT (aPTT) \< 2 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)
Exclusion Criteria:
Drug: Ruxolitinib
Participants will receive ruxolitinib orally twice daily for 24 weeks.
Number of participants with ruxolitinib treatment response
Treatment response is defined by stable and/or improved lung function as defined by the National Institutes of Health Chronic GVHD Response Criteria Working Group.
Time frame: 6 months from early lung dysfunction diagnosis
Percentage of participants with JAK inhibition
The presence of JAK inhibition will be measured by phospho stat5
Time frame: 24 weeks after ruxolitinib initiation
Number of participants with lung function response measured by a Xenon MRI scan
The presence of a lung function response will be measured by a Xenon MRI scan
Time frame: 24 weeks after ruxolitinib initiation
Number of participants with lung function response measured by oscillometry
The presence of a lung function response will be measured by oscillometry
Time frame: 24 weeks after ruxolitinib initiation
Number of participants with lung function response measured by home spirometry
The presence of a lung function response will be measured by home spirometry
Time frame: 24 weeks after ruxolitinib initiation
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati