Itacitinib for Bronchiolitis Obliterans Syndrome

Recruiting in Palo Alto (17 mi)

Overseen by Amin Alousi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

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.

Treatment Details

Interventions

• Itacitinib (Janus Kinase (JAK) Inhibitor)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

References