Could a cancer drug help lung damage after transplant?
NCT ID NCT03674047
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 study tests the drug ruxolitinib (Jakafi) in 50 people who developed bronchiolitis obliterans syndrome (BOS) after a stem cell transplant. BOS is a serious lung condition that causes scarring and breathing problems. The goal is to see if ruxolitinib can improve lung function and control the disease by reducing inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ruxolitinib (also known as Jakafi)
- What this could lead to
- If successful, this could offer a new treatment option to improve lung function and slow disease progression in patients with bronchiolitis obliterans syndrome after transplant.
- What could go wrong
- This is a small, early-phase study with only 50 participants. The drug may not work for everyone, and side effects like infection or blood issues are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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50 people
The number who actually took part.
- Started
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Apr 2019
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosis of BOS after HCT defined when all of the following criteria are met (as defined by the 2014 NIH criteria): * FEV1/VC \< 0.7 or the 5th percentile of predicted. * FEV1 = Forced Expiratory Volume in 1 second. * VC = Vital Capacity (Forced Vital Capacity "FVC" or Slow Vital Capacity "SVC", whichever is greater) * The 5th percentile of predicted is the lower limit of the 90% confidence interval. * For elderly patients, use the lower limits of normal defined according to NHANESIII calculations. * FEV1 \<75% of predicted with ≥ 10% absolute decline over less than 2 years. FEV1 should not correct to \>75% of predicted with albuterol, and the absolute decline for the corrected values should still remain ≥ 10% over 2 years. The remote comparator would be an evaluation of PFTs done within 2 years of the PFTs assessment being evaluated to determine eligibility. * Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage). * One of the two supporting features of BOS: * Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT OR * Evidence of air trapping by PFTs: RV (Residual Volume) \> 120% of predicted or RV/TLC elevated outside the 90% confidence interval (RV/Total Lung Capacity). * Life expectancy \> 6 months at the time of enrollment as judged by the enrolling investigator. * Male or female; 18-75 years old. * ECOG Performance Status 0-2. * At least 4 weeks since initiation of the most recent systemic therapy for cGVHD or BOS * All females of childbearing potential must have a negative serum or urine pregnancy test \< 7 days before study drug administration. * The ability to understand and willingness to sign a written consent document Exclusion Criteria: * Recurrent malignancy or disease progression requiring anticancer therapy. * Currently receiving or have previously received ruxolitinib for chronic GVHD therapy. * Known history of allergy to ruxolitinib or its excipients. * Pregnant females or nursing mothers. * Hepatic dysfunction: transaminases (ALT, AST) \> 5X ULN and/or total bilirubin \> 3X ULN. * Hematologic dysfunction: absolute neutrophil count \<1000/μL, platelet cout \<50K, and/or Hgb \< 8 g/dL. * Renal dysfunction: calculated creatinine clearance \< 40 mL/min (Cockcroft-Gault formula) * Receipt of any non-FDA approved study medication within the last 4 weeks (This does not apply to use of FDA-approved drugs for an off-label indication). * Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection. * Known human immunodeficiency virus infection. * Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Subjects with previous positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment. * Severe organ dysfunction unrelated to underlying GVHD, including: Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction). * Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy. * Clinically active asthma (variable and recurring symptoms of airflow obstruction and bronchial hyper-responsiveness), chronic obstructive pulmonary disease, interstitial lung disease, or cryptogenic organizing pneumonia or other causes of restrictive lung disease such as neuromuscular weakness or diaphragmatic paralysis. * Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements. * Uncontrolled substance abuse or psychiatric disorder. * Deemed (by the local PI or the PFT lab) unable to reliably perform pulmonary function tests. * Active smoker of cigarettes or marijuana.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Cancer Center
Duarte, California, 91010, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
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H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Other studies related to the condition(s) this trial covers.
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