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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
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
absolute FEV1 increase
Treatment failure
Secondary study objectives
Change scores for PFT measurements
Improvements in chronic GVHD organ manifestations
The incidence and types of serious adverse events
+1 more

Side effects data

From 2022 Phase 3 trial • 458 Patients • NCT04530344
13%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib 1.5% Cream BID
Vehicle Cream BID
Total

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Incyte CorporationIndustry Sponsor
388 Previous Clinical Trials
63,585 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,000 Previous Clinical Trials
13,308,498 Total Patients Enrolled
4 Trials studying Other Cancers
30,301 Patients Enrolled for Other Cancers
Zachariah DeFilipp, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
120 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
~8 spots leftby Oct 2025
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