Itacitinib for Bronchiolitis Obliterans Syndrome

Overseen By Amin Alousi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: JAK inhibitors

Disqualifiers: HIV, Hepatitis B/C, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a drug called itacitinib for individuals with bronchiolitis obliterans syndrome, a serious lung condition, following a donor cell transplant. The aim is to determine if itacitinib can prevent disease progression by blocking certain enzymes that promote cell growth. Suitable candidates for this trial include those diagnosed with bronchiolitis obliterans syndrome within the last six months who have undergone a donor stem cell transplant. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that itacitinib has been tested for safety in patients with bronchiolitis obliterans syndrome (BOS) following lung transplants. Some patients experienced stable or improved lung function, suggesting the treatment might be well-tolerated.

This trial is in the early stages, focusing mainly on safety. During these phases, researchers closely monitor participants for any side effects. While itacitinib looks promising, detailed safety information is still being collected.

For those considering joining the trial, medical professionals are carefully monitoring the treatment to ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Bronchiolitis Obliterans Syndrome, which typically involve corticosteroids and immunosuppressive drugs, itacitinib offers a new approach by targeting specific pathways involved in inflammation. Itacitinib is a Janus kinase (JAK) inhibitor, which blocks the activity of enzymes that play a role in the inflammatory process. This targeted action could potentially reduce inflammation more effectively and with fewer side effects. Researchers are excited about itacitinib because it represents a promising new direction in managing this challenging condition, potentially offering better outcomes for patients.

What evidence suggests that itacitinib might be an effective treatment for bronchiolitis obliterans syndrome?

Research has shown that itacitinib, the treatment under study in this trial, might help maintain or even improve lung function in some individuals with bronchiolitis obliterans syndrome (BOS). In one study, some patients experienced stable or improved lung function after starting itacitinib treatment, suggesting the drug could be promising for those with worsening BOS. Itacitinib blocks certain enzymes that promote the growth of harmful cells, potentially helping to manage BOS symptoms. Although further research is necessary, these early results offer encouragement for those considering itacitinib as a treatment option. ^{2 3 4 5 6}

Who Is on the Research Team?

Amin Alousi, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults aged 18-75 who've had a donor stem cell transplant and are now facing a lung condition called bronchiolitis obliterans syndrome (BOS) can join. They need to be in decent health otherwise, with specific blood counts, and able to understand the study. Women of childbearing age must not be pregnant or nursing, and all participants should avoid having children during the trial.

Inclusion Criteria

I am using a highly effective birth control method.

You have been diagnosed with BOS (Bronchiolitis Obliterans Syndrome) in the last 6 months, as defined by specific medical guidelines.

I agree not to donate sperm during and for 3 months after the study.

Exclusion Criteria

My cancer came back after a stem cell transplant.

You are currently using a ventilator or your oxygen levels are consistently below 88%.

I haven't taken JAK inhibitors like Ruxolitinib in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive itacitinib orally once daily for up to 1 year in the absence of disease progression or unacceptable toxicity

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 3 and 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Itacitinib

Trial Overview The trial is testing Itacitinib's effectiveness for BOS after stem cell transplants. This early-phase study will see if blocking certain enzymes with Itacitinib stops harmful cell growth that contributes to this lung condition.

How Is the Trial Designed?

Group I: Treatment (itacitinib) Experimental Treatment 2 Interventions

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

Itacitinib is already approved in European Union, United States for the following indications:

Approved in European Union as Itacitinib for:

• Graft-versus-host disease

Approved in United States as Itacitinib for:

• Graft-versus-host disease

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. jhltonline.org jhltonline.org/article/S1053-2498(22)00281-9/abstract

Efficacy and Safety of the Janus Kinase 1 Inhibitor Itacitinib ... Lung function stabilized or improved in a subset of pts who were treated with ITA following a recent diagnosis with progressive BOS stage 1-3.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04446182

Itacitinib (INCB039110) and Extracorporeal Photopheresis ... An open-label, Phase II trial designed to assess the recommended phase 2 dose (RP2D) of itacitinib in combination ECP and efficacy of the combination after ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11545638/

Time to Rethink Bronchiolitis Obliterans Syndrome Following ... Azithromycin is the most effective treatment for BOS, with a randomized, placebo-controlled trial showing a predicted FEV1 increase of 16–18% [ ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053249822002819

Efficacy and Safety of the Janus Kinase 1 Inhibitor Itacitinib ... Lung function stabilized or improved in a subset of pts who were treated with ITA following a recent diagnosis with progressive BOS stage 1-3.

5. ctv.veeva.com ctv.veeva.com/study/itacitinib-for-the-treatment-of-bronchiolitis-obliterans-syndrome-after-donor-hematopoietic-cell-tra

Itacitinib for the Treatment of Bronchiolitis Obliterans ... This phase I trial studies how well itacitinib works for the treatment of bronchiolitis obliterans syndrome after donor hematopoietic cell ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/37/NCT03978637/SAP_001.pdf

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating ... ... Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following. Lung Transplantation. NCT Number ...