Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06770842

Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis

Safety and Efficacy of Ropeginterferon Alfa-2b in Combination With Ruxolitinib in Patients With Myelofibrosis Demonstrating Suboptimal Response to Ruxolitinib Monotherapy

Status
Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
The University of Hong Kong · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

In this open-label single arm phase 2 study, approximately 20 patients with MF demonstrating suboptimal response to ruxolitinib monotherapy will be enrolled. Patients will continue to receive ruxolitinib at a stable dose and ropeginterferon alfa 2b will be added to the regimen.

Detailed description

Ropeginterferon alfa 2b is administered subcutaneously once every 2 weeks. Ruxolitinib is self-administered orally as part of standard of care. BSubjects will continue combination treatment through the Initial Treatment Period (ITP) (first 6 cycles), which includes a Qualification Assessment. Those deriving clinical benefit in the opinion of the treating physician may continue receiving combination treatment in the Additional Treatment Period (6 cycles). Qualification Assessments will be performed at the end of each Additional Treatment Period, which is iterative, and may repeat for as long as clinical benefit is sustained, at the discretion of the treating physician.

Conditions

Interventions

TypeNameDescription
DRUGRopeginterferon alfa-2b (BESREMi®)Ropeginterferon alfa 2b is administered subcutaneously once every 2 weeks. The dosing will be 250mcg at Week 0, 350mcg at Week 2, 500mcg at Week 4, and 500mcg every 2 weeks thereafter

Timeline

Start date
2025-03-01
Primary completion
2026-12-01
Completion
2027-12-01
First posted
2025-01-13
Last updated
2025-06-11

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT06770842. Inclusion in this directory is not an endorsement.