NCT03674047

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

A Phase II Study of Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved ruxolitinib for this specific disease but it has been approved for other uses. In this study the investigators are assessing the safety and effectiveness of ruxolitinib when given to participants who have been diagnosed with BOS after HCT. BOS is a sign/symptom of chronic Graft-vs-Host Disease (GVHD), a condition in which cells from the donor's tissue attack the organs after HCT occurs. Ruxolitinib blocks certain proteins called tyrosine kinases. Specifically, it blocks tyrosine kinases called JAK2. The investigators believe that ruxolitinib may lower the rate of GVHD through its ability to block the JAK2 pathway since this pathway can lead to inflammation in the body.

Conditions

• Other Cancer

Interventions

Type	Name	Description
DRUG	ruxolitinib	Ruxolitinib blocks certain proteins called tyrosine kinases. Specifically, it blocks tyrosine kinases called JAK2. it's believe that ruxolitinib may lower the rate of GVHD through its ability to block the JAK2 pathway since this pathway can lead to inflammation in the body

Timeline

• Start date: 2019-04-19
• Primary completion: 2022-12-02
• Completion: 2025-12-01
• First posted: 2018-09-17
• Last updated: 2025-11-10

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study