Ruxolitinib for Bronchiolitis Obliterans Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byZachariah DeFilipp, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study is studying a drug as a possible treatment for Bronchiolitis Obliterans Syndrome (BOS) after having an Allogeneic Hematopoietic Cell Transplantation (HCT).

Research Team

Zachariah DeFilipp, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults aged 18-75 with Bronchiolitis Obliterans Syndrome after a cell transplant, who have specific lung function test results and no active infections or severe organ dysfunction. Participants must not be pregnant, nursing, or have allergies to the study drug ruxolitinib.

Inclusion Criteria

You have at least one of two symptoms of bronchiolitis obliterans syndrome (BOS).

Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT OR

Evidence of air trapping by PFTs: RV (Residual Volume) > 120% of predicted or RV/TLC elevated outside the 90% confidence interval (RV/Total Lung Capacity).

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Exclusion Criteria

Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection.

Known history of allergy to ruxolitinib or its excipients.

Pregnant females or nursing mothers.

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Treatment Details

Interventions

Ruxolitinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe trial is testing ruxolitinib as a potential treatment for BOS in patients who've had an Allogeneic Hematopoietic Cell Transplantation. It aims to see if this drug can help improve lung function in these individuals.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: newly-diagnosed BOSExperimental Treatment1 Intervention

-Participants will take ruxolitinib twice every day

Group II: Established BOSExperimental Treatment1 Intervention

-Participants will take ruxolitinib twice every day

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

🇺🇸 Approved in United States as Jakafi for: