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Bronchiolitis ObliteransPhase 1NCT04239989

Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant

A Phase 1 study testing Itacitinib and Itacitinib Adipate in people with Bronchiolitis Obliterans, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial studies how well itacitinib works for the treatment of bronchiolitis obliterans syndrome after donor hematopoietic cell transplant. Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bronchiolitis Obliterans
What is being tested?
Itacitinib and Itacitinib Adipate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
8 Oct 2021to 31 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BOS diagnosed within the past 6 months of enrollment, defined by 2015 National Institutes of Health (NIH) Consensus Criteria 126
  • Age 18-75 years
  • Undergone allogeneic SCT
  • ANC >1,000/µL, hemoglobin > 8 gm/dL (untransfused) and platelet count >25,000/ µL (untransfused)
  • Karnofsky performance score >60
  • The ability to understand and sign a written informed consent form
  • Contraception for women and men of child bearing potential. Permitted methods should be at least 99% effective in preventing pregnancy.
  • 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.

Who cannot join

  • Prior treatment with any other JAK inhibitor (including Ruxolitinib) for BOS or any other indication within the past 6 months of enrolment.
  • Patients on mechanical ventilation or resting by pulse oximetry O2 saturation <88%
  • FEV1 <40% predicted
  • Relapsed primary malignancy for which SCT was performed
  • History of progressive multifocal leuko-encephalopathy (PML)
  • Active uncontrolled bacterial, fungal, parasitic, or viral infection
Show all 15Show fewer
  • Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infections.
  • History of tuberculosis anytime after SCT
  • Severe renal dysfunction defined by serum creatinine > 2 mg/dL, creatinine clearance <60 mL/minute or dialysis dependence
  • Serum transaminases > 5 × upper limit of normal
  • inability to perform PFT reliably
  • Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
  • Lactating/nursing women
  • Life expectancy < 6 months
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase I Study to Assess Safety of Selective JAK 1 Inhibitor, Itacitinib, in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplant (HCT)

This phase I trial studies how well itacitinib works for the treatment of bronchiolitis obliterans syndrome after donor hematopoietic cell transplant. Itacitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the safety of itacitinib in patients with bronchiolitis obliterans syndrome (BOS) after allogeneic hematopoietic cell transplantation (HCT).

SECONDARY OBJECTIVES:

  1. To assess treatment failure at 3 months and 6 months.

II. To assess change in symptom-based lung score at 3 months and 6 months.

III. To assess change in the St. George Respiratory Questionnaire and Study Short Form 36 at 3 months and 6 months.

IV. To assess change in the Lee chronic graft versus host disease (GVHD) symptom scale at 3 months and 6 months post-treatment.

  1. To assess change in 6-minute walk test at 3 months and 6 months.

VI. To assess failure-free survival at 6 months.

VII. To assess non-relapse mortality at 6 months.

VIII. To assess overall survival at 6 months.

OUTLINE:

Patents receive itacitinib orally (PO) once daily (QD) for up to 1 year in the absence of disease progression or unacceptable toxicity.

Being tested
Itacitinib, Itacitinib Adipate
Medical subject headings
Bronchiolitis Obliterans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ItacitinibDrug

    Also called INCB 039110, INCB-039110, INCB039110

    Given PO

  • Itacitinib AdipateDrug

    Also called INCB-039110 Adipate, INCB039110 Adipate

    Given PO

Study groups in NCT04239989
Study groupRoleWhat they receive
Treatment (itacitinib)ExperimentalPatents receive itacitinib PO QD for up to 1 year in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Itacitinib; Drug: Itacitinib Adipate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib

    Number of participants who develop DLT's after the administration of the study drug

    Measured: Up to 6 months

Secondary outcomes (9)

  1. Treatment failure

    Defined as a decrease in the absolute value of % forced expiratory volume in 1 second (FEV1) by 10% or more.

    Measured: At 3 and 6 months

  2. Changes in National Institutes of Health (NIH) symptom-based lung score

    Improvement in NIH symptom-based lung score; Score 0 (no symptoms), Score 1 (shortness of breath with stairs), Score 2 (shortness of breath on flat ground), and Score 3 (shortness of breath at rest or requiring oxygen

    Measured: At 3 and 6 months

  3. Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies

    Will include the St. George's Respiratory Questionnaire (SGRQ Regression models will include time, and different covariance structures will be included, including unstructured and autoregressive integrated moving average (ARIMA). The analysis will be adjusted for potential confounding variables. Participants will answer a St. George's Respiratory Questionnaire. (Very Poor, Poor, Fair, Good, Very Good)?

    Measured: Baseline and at 3 and 6 months

  4. Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies

    Will include the Lee chronic GVHD symptom scale Lee symptom scale. Regression models will include time, and different covariance structures will be included, including unstructured and autoregressive integrated moving average (ARIMA). The analysis will be adjusted for potential confounding variables. The Lee Chronic GVHD Symptom Scale is a 30 item instrument with 7 subscales (skin, eyes, mouth, lung, nutrition, energy and psych) containing 2-7 items. Response options range from 0-4 (0-Not at all, 1-Slightly, 2-Moderately, 3-Quite a bit, 4-Extremely).

    Measured: Baseline up to 6 months

  5. Change in well-established patient reported outcomes used in chronic graft versus host disease (GVHD) studies

    Will include the study Short Form 36 (SF-36), NIH lung symptom score and SF-36 due to the longitudinal nature of the observations. Regression models will include time, and different covariance structures will be included, including unstructured and autoregressive integrated moving average (ARIMA). The analysis will be adjusted for potential confounding variables.

    Measured: Baseline and at 3 and 6 months

  6. Change in 6-minute walk test

    Measured: Baseline and at 3 and 6 months

  7. Failure-free survival

    Will be assessed and monitored

    Measured: At 6 months

  8. Non-relapse mortality

    Defined as the absence of need for additional line treatment, non-relapse mortality and recurrent malignancy.

    Measured: At 6 months

  9. Overall survival

    Will be assessed and monitored

    Measured: At 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start8 Oct 2021
  3. Primary completion31 Oct 2025
  4. Study completion31 Oct 2025

Why it stopped: \<75% participation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04239989
Sponsor's protocol ID
2018-0489
Other IDs
NCI-2019-08252, 2018-0489
Status last verified
Nov 2025
First submitted
30 Dec 2019
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Itacitinib and Itacitinib Adipate in people with Bronchiolitis Obliterans, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: \<75% participation). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04239989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.

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