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Janus Kinase (JAK) Inhibitor

Ruxolitinib for Bronchiolitis Obliterans Syndrome

Phase 2

Waitlist Available

Led By Zachariah DeFilipp, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a drug to see if it can treat BOS, a condition that may occur after HCT, a procedure where blood cells are transplanted from one person to another.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Ruxolitinib may cause side effects such as blood disorders (low counts of different types of cells), kidney issues (reduced creatinine clearance), liver problems (elevated bilirubin or transaminases), and potentially increase the risk of infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

absolute FEV1 increase

Treatment failure

Secondary outcome measures

Change scores for PFT measurements

Improvements in chronic GVHD organ manifestations

Overall survival

+3 more

Side effects data

From 2022 Phase 3 trial • 458 Patients • NCT04530344

13%

COVID-19

100%

80%

60%

40%

20%

Study treatment Arm

Ruxolitinib 1.5% Cream BID

Total

Vehicle Cream BID

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor

364 Previous Clinical Trials

55,115 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,305 Total Patients Enrolled

4 Trials studying Other Cancers

30,301 Patients Enrolled for Other Cancers

Zachariah DeFilipp, MDPrincipal InvestigatorMassachusetts General Hospital

5 Previous Clinical Trials

98 Total Patients Enrolled

Media Library

Ruxolitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03674047 — Phase 2

Other Cancers Research Study Groups: newly-diagnosed BOS, Established BOS

Other Cancers Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT03674047 — Phase 2

Ruxolitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03674047 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment for this trial?

"Affirmative. Clinicaltrials.gov hosts data that confirms this clinical trial's ongoing recruitment process, which began on April 19th 2019. Currently the research team is seeking 50 participants from one medical facility for their study and have most recently edited it on September 30th 2021."

Answered by AI

Does the study currently cater to individuals over 30 years of age?

"The requirements for participation in this investigation stipulate that the minimum age is 18, while the maximum age to enroll is 75."

Answered by AI

Are there any opportunities to participate in this medical experiment presently?

"The trial is open for enrollment, with its initial posting on April 19th 2019 and the most recent edit having occurred on September 30th 2021. This information can be found at clinicaltrials.gov."

Answered by AI

Who is eligible to become a participant in this medical experiment?

"This medical trial is admitting 50 bronchiolitis patients aged between 18 and 75. To qualify, applicants must meet the following criteria: Vital Capacity (FVC or SVC); 5th percentile of predicted as lower limit of 90% confidence interval; FEV1/VC < 0.7 or at least the 5th percentile of predicted; Forced Expiratory Volume in 1 second should be less than 75% if with ≥ 10% absolute decline over 2 years; elderly patients need to adhere to NHANESIII calculations for their normal limits; Residual Volume > 120% or RV/Total Lung Capacity outwith 90%. Additionally"

Answered by AI

Has the FDA granted approval to ruxolitinib?

"The safety of ruxolitinib is rated a 2 on the 1 to 3 scale, as there has been some evidence collected that suggests it may be safe but no proof yet demonstrating efficacy."

Answered by AI

What is the typical application of ruxolitinib?

"Ruxolitinib has been known to be efficacious in treating polycythemia vera, polycythemia and cases where hydroxyurea is either ineffective or intolerable."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)

Zachariah Michael DeFilipp 2019. "Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03674047.

All > Bronchiolitis Obliterans