Experimental drug tested for rare lung condition after transplant
NCT ID NCT04239989
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested the safety of a drug called itacitinib in 8 adults who developed bronchiolitis obliterans syndrome (a type of lung scarring) after receiving a stem cell transplant from a donor. The goal was to see if the drug could help control the lung disease by blocking certain enzymes. The study was terminated early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Oct 2025
- 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: 1. BOS diagnosed within the past 6 months of enrollment, defined by 2015 National Institutes of Health (NIH) Consensus Criteria 126 2. Age 18-75 years 3. Undergone allogeneic SCT 4. ANC \>1,000/µL, hemoglobin \> 8 gm/dL (untransfused) and platelet count \>25,000/ µL (untransfused) 5. Karnofsky performance score \>60 6. The ability to understand and sign a written informed consent form 7. Contraception for women and men of child bearing potential. Permitted methods should be at least 99% effective in preventing pregnancy. 8. Male patients must be willing to refrain from donating sperm during their participation in the study and for at least 3 months after completing the study. Exclusion Criteria: 1. Prior treatment with any other JAK inhibitor (including Ruxolitinib) for BOS or any other indication within the past 6 months of enrolment. 2. Patients on mechanical ventilation or resting by pulse oximetry O2 saturation \<88% 3. FEV1 \<40% predicted 4. Relapsed primary malignancy for which SCT was performed 5. History of progressive multifocal leuko-encephalopathy (PML) 6. Active uncontrolled bacterial, fungal, parasitic, or viral infection 7. Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infections. 8. History of tuberculosis anytime after SCT 9. Severe renal dysfunction defined by serum creatinine \> 2 mg/dL, creatinine clearance \<60 mL/minute or dialysis dependence 10. Serum transaminases \> 5 × upper limit of normal 11. inability to perform PFT reliably 12. Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. 13. Lactating/nursing women 14. Life expectancy \< 6 months 15. Other severe organ dysfunction unrelated to underlying GVHD. For example, uncontrolled or significant cardiac disease, including any of the following: recent myocardial infarction (within last 6 months from randomization); New York Heart Association Class III or IV congestive heart failure; unstable angina (within last 6 months prior to randomization); clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular; tachycardia, and clinically significant second or third degree AV block without a pacemaker); uncontrolled hypertension. Or any other concurrent severe and/or uncontrolled medical conditions which, in the opinion of the investigator, could compromise participation in the study, pose a significant risk to the subject, or interfere with study results.
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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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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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