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

NCT04239989 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: 2018-0489NCI-2019-08252
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchiolitis Obliterans

Outcome Measures

Primary Outcomes (1)

• Monitoring the Dose Limiting Toxicities (DLT) of administering Itacitinib

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

  Up to 6 months

Secondary Outcomes (9)

• Treatment failure

  At 3 and 6 months

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

  At 3 and 6 months

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

  Baseline and at 3 and 6 months

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

  Baseline up to 6 months

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

  Baseline and at 3 and 6 months

Study Arms (1)

Treatment (itacitinib)

EXPERIMENTAL

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

Drug: Itacitinib; Drug: Itacitinib Adipate

Interventions

Itacitinib DRUG

Given PO

Also known as: INCB 039110, INCB-039110, INCB039110

Treatment (itacitinib)

Itacitinib Adipate DRUG

Given PO

Also known as: INCB-039110 Adipate, INCB039110 Adipate

Treatment (itacitinib)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Bronchiolitis Obliterans

Interventions

itacitinib; INCB039110

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Amin Alousi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 27, 2020
• Study Start: October 8, 2021
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)