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

8 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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.

Research Team

Amin Alousi, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+