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Experimental drug tested for rare lung condition after transplant

NCT ID NCT04239989

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Oct 2021

Finished

Oct 2025

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

Bronchiolitis Obliterans bronchiolitis obliterans syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 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.